arr _arun product final pdf-000200144229

ANNUAL REVIEW REPORT- PRODUCT

This document is electronically generated.

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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)

ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229

Reviewed Period: October-2014 to October-2015

ANNUAL REVIEW REPORT OF

LIP-3 (OLANZAPINE

CANADIAN MKT)



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DOCUMENT APPROVAL SHEET

Department Name and Designation Signature

Compiled By:

External Consultants HP - Adinarayana Reddy Chennepalli Consultant

P90003214 06.10.2015 11:29:28

Reviewed By:


P90003214 06.10.2015 11:53:52

Approved By:


P90003214 06.10.2015 12:19:43



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TABLE OF CONTENTS

S.NO. CONTENT PAGE NO.

1.0 PRODUCT DESCRIPTION 4

2.0 BATCH PRODUCTION AND DISPATCH DETAILS 5

3.0REVIEW OF STARTING MATERIALS & PACKAGING MATERIALS FROM NEW SOURCE 6

4.0 REVIEW OF BIO-BURDEN ON PRODUCT 8

5.0 REVIEW OF OOS & OOT RESULTS 9

6.0 REVIEW OF REPROCESS & REWORK 11

7.0 REVIEW OF INCIDENTS 12

8.0 REVIEW OF CHANGE CONTROLS 19

9.0 REVIEW OF STABILITY MONITORING PROGRAM 28

10.0 REVIEW OF CUSTOMER COMPLAINTS,RETURNED GOODS & RECALLS 31

11.0 REVIEW OF VALIDATION ACTIVITIES 34

12.0 REVIEW OF REGULATORY FILING STATUS 36

13.0 REVIEW OF RETAINED SAMPLES(FINISHED PRODUCT) 37

14.0 REVIEW OF QUALITY TRENDS OF API STARTING MATERIAL 38

15.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF INTERMEDIATE STAGE(S) OF PRODUCT

39

16.0 REVIEW OF QUALITY TRENDS OF INTERMEDIATE STAGE(S) OF PRODUCT

40

17.0 REVIEW OF YIELD TRENDS OF INTERMEDIATE STAGE OF PRODUCT 41

18.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF FINISHED STAGE(S) OF PRODUCT

42

19.0 REVIEW OF QUALITY TRENDS OF API (FINISHED) STAGE OF PRODUCT 43

20.0 REVIEW OF YIELD TRENDS OF API (FINISHED) STAGE OF PRODUCT 148

21.0 REVIEW OF LAST ARR 151

22.0 SUMMARY REPORT 152

23.0 CONCLUSION AND RECOMMENDATIONS 172

ANNEXURE - III

ANNEXURE - II

ANNEXURE - I



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1.0 PRODUCT DESCRIPTION :


Type of Product: API

SAP Code: 200001445

Chemical Name: Sample for testing

Codes of Manufacturing Stages:

Intermediate Product Code Description

200001445 LIP-3 (OLANZAPINE CANADIAN MKT)

Key Starting Material Code Description


API Description






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2.0 BATCH PRODUCTION AND DISPATCH DETAILS:

2.1 Summary of Production of Intermediates and API batches:

Product Stage(Intermediate/

API)

Product Stage Code

No. Of Batches Manufactured

Quantity Manufactured UOM Material Type

200001445(API) LIP-3 (OLANZA 00001 9.100 KGМер.графік з

контирув.операцій (вн.нум.)

200001445(API) LIP-3 (OLANZA 00152 1366.300 KGNormal Production

Process

200001445(API) LIP-3 (OLANZA 00026 230.400 KG Packing order

200001445(API) LIP-3 (OLANZA 00001 8.600 KG Process Order - Recovery (2nd Corp)

200001445(API) LIP-3 (OLANZA 00005 32.400 KG Reprocess order

2.2 Dispatch Details of Product:(Market)

S.No Market Name Qty. (in Kg)

NA NA NA

Total 0.000

2.3 Dispatch Details of Product(FTO):

S.No Plant Qty. (in Kg)

1 6052 915.500

Total 915.500



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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)



3.0 REVIEW OF STARTING MATERIALS & PACKAGING MATERIALS FROM NEW SOURCE:

3.1 Raw Materials:

S.No Material Name/Code Source Details Status of vendor

Date of Approval Remarks

NA NA NA NA NA NA

QA Final Comments

Reviewed Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:07:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 15:59:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35

3.2 Packaging Materials:

S.No Material Name/Code Source Details Status of vendor

Date of Approval Remarks

1 APPROVED VENDOR()SAMPLE FOR

TESTINGAPPROVED

VENDOR16-10-2014 NA



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QA Final Comments

Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:07:54 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 15:59:23 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35



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ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229


4.0 REVIEW OF BIO BURDEN ON PRODUCT:

200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of

Specification Ref. No.

S.No. Batch No.

QA FINAL COMMENTS:



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5.0 REVIEW OF OOS & OOT RESULTS:

5.1 Summary of OOS Results:

S.No Product Stage Code

OOS Notification

No.

Date of Reporting Batch No. Description of

OOSInvestigation Status

Batch Status

1 16-10-2015 ADIH000198

Inspection Spec

Accepted

QA Final Comments

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52

5.2 Summary of OOT Results:

S.No.

Product Stage Code

OOT Notification

No.

Date of Reporting Batch No. Description of OOT Investigati

on StatusBatch Status



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QA Final Comments

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 sss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52



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6.0 REVIEW OF REPROCESS & REWORK:6.1 Summary of Reprocessing & Reworking of Intermediates and API Batches:

Material Code Material In-house Stage Code

No. of Batches Reprocessed

Quantity Produced by Reprocess (Kg)

No. of Batches Reworked

Quantity Produced by Rework (Kg)

200001445 LIP-3 1 6.200 0 NA

200001445 LIP-3 1 5.200 0 NA

200001445 LIP-3 1 8.600 0 NA

200001445 LIP-3 1 6.300 0 NA

200001445 LIP-3 1 6.100 0 NA

QA Final Comments

Reprocessed batch nos. that failed meeting specification: 0 ,ADIH001371 Reworked batch nos. that failed meeting specification: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:58 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:58 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:20:39 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:40 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:47 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:54:27



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7.0 REVIEW OF INCIDENTS:

7.1 Summary of Incidents:

S.NO Batch No. Incident No. Date of Reporting Description of Incident

Status of Incident

Investigation

Root Cause (if Identified)

1 NA 200109073 17-10-2014

0 While processing the RS/HPLC chromatogram of Olanzapine F-1 bearing B.No.ADHH001302, the baseline of the sample found not good.

CLOSED NA

2 NA 200110553 13-11-2014

LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003499 Obtained additional peaks in XRD test. Result : Sample XRD pattern does not matches with standard. Specification: To match with working standard. OOS number: OOS07014

CLOSED NA

3 NA 200110554 13-11-2014

LIP-3 Stage of Olanzapine (Form-1) having batch number ADHH003500 Additional peaks are observed. Result : Sample pattern does not matches with standard. Specification: To match with working standard. OOS Number : OOS07114

CLOSED NA

4 NA 200112085 14-11-2014

LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003527 Additional peaks observed in XRD test. Result : Does not matches with working standard. Specification: To match with working standard. OOS Number : OOS07214

CLOSED NA



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Status of Incident

Investigation


5 NA 200112270 17-11-2014

LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003527 In Related substances by HPLC, the Total impurities after summing Method-1+ Method-2 is observed as OOT. Result: Total impurities (Method-1 + Method-2) = 0.17% Specification: Not more than 0.2% OOT number: OOT05514

CLOSED NA

6 NA 200114407 08-12-2014

As per EP analysis: 1. LIP-3 stage of Olanzapine Form-1 (Canada) batch number ADGH002297 was found to be out of control limit with respect to Total impurities, result is 0.19% against the control limit of 0.06-0.18%. 2. LIP-3 stage of Olanzapine Form-1 (Canada) batch number ADGH002189 was found to be out of control limit with respect to Methylene Di chloride content, result is 321ppm against the control limit of87-263ppm. As per In house analysis: 1. LIP-3 stage of Olanzapine Form-1 (Canada) batch numbers ADHH001184 and ADHH001330 were found to be out of control limit with respect to Methylene Dichloride content, results are 241ppm and 463ppm respectively= <(>,<)> against the control limit of 87-263ppm.

CLOSED NA



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Status of Incident

Investigation


7 NA 200116035 21-12-2014 For LIP-3 bearing Batch No.ADHH003940 Water content by KF result obtained as 0.00%.

CLOSED NA

8 NA 200117161 31-12-2014

In LIP-3 stage of Olanzapine (Form-1) having B.NO:ADEH003449 initiated for stability study. During long term stability study at 36 months found OOS in related substance by HPLC in any other Impurity and Total impurities as per in house specification. Details are: Result: Any other impurity: 0.23% and Total Impurities: 0.66% Specification: Any other impurity: Not more than 0.10% and Total Impurities: 0.50%

NA

9 ADEH003449

200117336 03-01-2015

The Out of specification was observed in Olanzapine F-1 (Canada) stability batch with No. ADEH003449 LT 36M in Related substances by HPLC as per In house Spec and MOA.

CLOSED NA

10 NA 200117528 06-01-2015

LIP-3 stage of Olanzapine (Form-1) having Batch No: ADIH000038 at op No: 54(drying operation) in-process water content (Sample No.LIP-3-02) result obtained as 0.8% W/W against the Limit 0.5% W/W

CLOSED NA



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Status of Incident

Investigation


11 ADGH001516

200118309 13-01-2015

The "Out of specification" in Related substances by HPLC - "Any Other Impurity" impurities and “Out of trend” for Total impurities as per Spec and MOA S-08-OI-USP/01 was found .The Out of specification in Related substances by HPLC for Unspecified and Total impurities as per S-08-OI-Ph.Eur/01 was found.

CLOSED NA

12 NA 200124845 09-03-2015

In LIP-3 stage of Olanzapine (Form-1) Canada having Batch Number ADIH000580, unspecified impurity in related substance by HPLC (Method-1) and Total impurities in related substance by HPLC (Method-1+Method-2) as per Ph. Eur results obtained as OOT. Unspecified impurity result: 0.10% Specification: NMT 0.10% Total impurities result: 0.24% Specification: NMT 0.2% OOT NO: OOT 02015

CLOSED NA

13 NA 200126960 26-03-2015

LIP-3 Stage of Olanzapine (Form-1) having Batch number ADIH000874 multiple strike off's observed at operation number 52 at page 40 of 45

CLOSED NA



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Status of Incident

Investigation


14 NA 200128463 09-04-2015

LIP-3 stage of Olanzapine (Form-1) having Batch No: ADIH000989 at op No: 54(drying operation) in-process water content (Sample No.LIP-3-02) result obtained as 0.6% W/W against the Limit 0.5% W/W

CLOSED NA

15 NA 200129582 17-04-2015

LIP-3 stage of Olanzapine (Form-1) Batch No. ADIH000988 water content result obtained as out of trend. Result: 0.41%W/W Specification: Not more than 0.5%W/W OOT No.: OOT 03415

CLOSED NA

16 NA 200129583 17-04-2015

LIP-3 stage of Olanzapine (Form-1) Batch No. ADIH000989 water content result obtained as Out of trend. Result: 0.50%W/W Specification: 0.5%W/W OOT No. : OOT 03515

CLOSED NA

17 NA 200133147 19-05-2015

LIP-3 Stage of Olanzapine (Form-1)having Batch number ADIH001270 In related substance by HPLC LIP-2 Quaternary salt impurity result obtained as OOT. Specification: LIP-2 Quaternary salt not more than 0.15% Result : 0.14% OOT number : OOT05215

CLOSED NA



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Status of Incident

Investigation


18 NA 200133352 20-05-2015

Lip-3 stage of Olanzapine (Form-1) having Batch NO: ADIH001372 water content result as out of trend as per in house method. Result: 0.5% W/W Specification: NMT 0.5% W/W OOT NO: OOT 05315

CLOSED NA

19 NA 200135307 07-06-2015

In LIP-3 stage of Olanzapine (Form-1) Canada having Batch Number ADIH001419 Total impurities result obtained as Out of trend as per Ph.Eur. Result: 0.20% Specification: NMT 0.2% OOT No. OOT06015

CLOSED NA

20 ADIH001583 200136601 17-06-2015

In LIP-3 stage of Olanzapine (Form-1), during sample collection of ADIH001583 batch (dated on 17.06.2015 at 9:20 hrs), wetness was observed on the inner surface of the black polybag which is one of the three layers of packing material used for product packing. Hence the sample was not collected by the analyst.

CLOSED NA

21 ADIH001583 200144255 16-10-2015

In LIP-3 stage of Olanzapine (Form-1), during sample collection of ADIH001583 batch (dated on 17.06.2015 at 9:20 hrs), wetness was observed on the inner surface of the black polybag which is one of the three layers of packing material used for product packing. Hence the sample was not collected by the analyst.

CLOSED NA

QA Final Comments



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Total no. of incidents reported during this review period: 20 No. of incidents closed: 19 No. of incidenets open: 0 No. of incidents of previous rev period closed in this rev period: 0 No. of incidents of previous rev period still open in this rev period: 0 Total no. of CAPAs raised during the review period: 0 No. of CAPAs closed: 0 No. of CAPAs open: 0 No. of CAPAs that crossed timeline, but closed: 0 No. of overdue open CAPAs: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:28:08 great Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:28:08 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:21:25 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:02:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:55:07



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8.0 REVIEW OF CHANGE CONTROLS:

S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required

InDescription of Change

Category of Change

(Major/Minor)

Current status of Closure

1 21-10-2014200109569 Permanent Change

Product and

Process/Permanent Change

To assign the shelf life for Olanzapine F-1 (Canada) as per USP as 24 months.

Minor OPEN

2 01-12-2014200113672 Temporary Change

Material/Material

Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches.

Minor OPEN


Document/Batch

production record

I.,,Proposed to obsolete the LIP-3 stage batch production records with the form no.s F-10-729/00 (Wet BPR) & MF.No.: MF-LIP-3-007/00 and F-10-730/00 (Dry BPR) & MF.No.: MF-LIP-3-007/00 II.,,Proposed to obsolete the LIP-3R stage batch production records with the form no.s F-10-731/00 (Wet BPR) & MF.No.: MF No.: MF-LIP-3R-019/00 and F-10-732/00(Dry BPR) & MF No.: MF-LIP-3R-019/00

Minor OPEN



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Document/Change in formats

1) The Olanzapine F-1 (Canada) shall be assigned shelf life of 24 months Expiry as per In house, USP and Ph.Eur and the same shall be mentioned in templates of Spec and MOA’s. (List enclosed) 2)Proposed to remove the 36th,48th and 60th month stability samples of Olanzapine F-1 (Canada) from the chamber and conduct the stability study till 24 months based on the shelf life assigned i.e, 24 Months expiry Period and accordingly to revise the stability data sheets. F-20-347/06, F-20-557/02, F-20-714/01, for In-House, USP and Ph.Eur sub sequentially. List of batches with intervals to be removed is enclosed

Minor OPEN


Material and

Process/Change Control

issu

The Olanzapine F-1 Canada shall be assigned expiry period 18 months as per In house, USP and Ph.Eur and the same shall be mentioned in templates of Spec and MOA’s. Major CLOSED



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Document/Batch

production record

I. LIP-3 scale-up: Proposed to revise LIP-3 scale-up BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3 stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-781/09 & MF-LIP-3-008/01. II. LIP-3 scale down: Proposed to revise LIP-3 scale down BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3 stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-245/15 & MF-LIP-3-005/05 III. LIP-3R: Proposed to revise LIP-3R BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3R stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13 . Proposed document No.: F-10-404/10 & MF-LIP-3R-017/02 IV. LIP-3RD: Proposed to revise LIP-3RD BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3RD stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-799/02

Minor OPEN



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Product/Product

Proposed to revise in process and intermediate water content limit LIP-2/LIP-22/LIP-2RC/LIP-2R stage as NMT 8.0% w/w

Minor CLOSED


Document/STP/MOA

1) S-09-LIP3-01/06 2) Propose to revise LIP-3 Rinsed / Swab sample spec & MOA with specification limit is NMT: 1.96 ppm

Minor OPEN


Document/STP/MOA

1) S-08-OI-Ph.Eur/02& CS-OI-003/10 ( Actavis EDMF spec & MOA) 2) Propose to revise Olanzapine form-1 Canada Ph.Eur & Actavis customer spec & MOA's with test sample weight is 2 g in Heavy Metals Method of analysis.

Minor CLOSED



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Document/STP/MOA

1.1) Revise Spec No : S-08-OI/14 in-house 1.2)Propose to revise Olanzaine form-1 in-house spec & MOA with Moisture Content method of analysis media is Methanol and test sample is about 1.0 g. 1.3)S-08-OI-Ph.Eur/02 1.4) Propose to revise Olanzaine form-1 Ph.Eur spec & MOA with Water Content method of analysis media is Methanol and test sample is about 1.0 g. 1.5)ROA's are revised with current versions : 200001445-V09 , 200001445-Ph.Eur-V04<(>,<)> 200001445-STAB-EP-V03 & 200001445-STAB-IH-V03

Minor CLOSED


Equipment and

Process/Process

Proposed to take trials using Hyflo modular filter. The trial material samples will be analyzed in QC.

Minor OPEN


Equipment and

Facility/Equipme

nt and Fac

,,In this system primary condenser will be installed horizontally and 100% area will be utilized. Secondary condenser will be installed inside the plant with balancing line and completely smell of DMSO will be reduced.

Minor CLOSED



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Document/STP/MOA

Propose to revise the water by KF method with media as Acetic acid and Methanol (5:50) for Olanzapine form-1 (Canada) Finished (In-house) and in process spec & MOA. Proposed Specification No.s: Finished: S-08-OI/14 In process: S-02-LIP-3-02/04 To revise ROA of Finished product with current version No : 200001445-V09

Minor CLOSED


Document/STP/MOA

Proposed to harmonize Olanzapine (Form-1) (LIP-3) HPLC method of analysis (Related substances and Assay by HPLC) by adopting USP MOA Propose to include additional method of analysis (Other pharmacopeias & In-house methods) as alternative for chemical analysis in all Spec. & MOAs. Method details and List of specification which shall be revised. Annexure are enclosed.

To be identified OPEN



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8.1 Summary of Approved Change Controls:

S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Document/Batch

production record

Proposed to regularize the validated changes of LIP-2 scale up for 85.00 (±5.00) Kg input batch size of LIP-1/LIP-1R by regularizing the BPR. Major process changes are as follows. i) Acetic acid Lot-1 Qty. is used as 7.0 L (6.6-7.4 L) instead of 3.4 L (3.2-3.6 L) for 1st Re-crystallization process. ii) Acetic acid Lot-2 Qty. is used as 11.5 L (10.8-12.2 L) instead of 7.8 L (7.3-8.3 L) for 2nd Re-crystallization process. iii) Dimethyl sulfoxide Lot-4 Qty. is used as 194.0 L (183.0-205.0 L) instead of 170.0 L (160.0-180.0 L) for 2nd Re-crystallization process. iv) DM water II Lot-7 Qty. is used as 50.0 L (47.0-53.0 L) instead of 44.0 L (41.0-46.0 L) for 2nd Re-crystallization process. v) Dimethyl sulfoxide Lot-6 Qty. is used as 158.0 L (149.0-167.0 L) instead of 134.0 L (126.0-141.0 L) for 3rd Re-crystallization process vi) Dimethyl sulfoxide Lot-7 Qty. is used as 180.0 L (i.e; 6 times to the third RC wet weight qty. of 30 Kg) instead of 135.0 L (i.e 4.5 times of the 3rd RC wet quantity of 30 Kg) for 4th Re-crystallization process vii) DM water II Lot-11 Qty. is used as 45.0 L (i.e; 1.5 times to the third RC wet weight qty. of 30 Kg) instead of 30.0 L (i.e; 1 time of the 3rd RC wet quantity of 30 Kg) for 4th Re-crystallization process viii) DM water II Lot-12 Qty. is used as 121.0 L (114.0-128.0 L) for washing of wet cake instead of 60.0 L (i.e; 2 times of the 3rd RC wet quantity of 30 Kg) during centrifugation in 4th Re-crystallization process Operational changes are captured in the change annexure and is attached to the document link. Proposed document No.: F-10-765/13 & MF-LIP-2-009/01

Minor CLOSED



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S.No

Date of Initiation

Notification No.

Type of change

(Temporary/

Permanent)

Change Required


Category of Change

(Major/Minor)



Material/Material

Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches. To be

identified OPEN


MATERIAL/

MATERIAL

Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches. To be

identified OPEN

QA Final Comments

Total no. of change control inititated: 16 No. of change control closed: 7 No. of change control open: 9 No. of change control of previous rev. period closed in this 0 No. of change control of previous rev. period still open at 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:29:11 good Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:29:11 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:23:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On



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:06/10/2015 at 11:10:59 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:03:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:56:32



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9.0 REVIEW OF STABILITY MONITORING PROGRAM:

9.1 Accelerated Stability Studies:

Temperature/RH :

Packaging Condition:

S.No. Batches kept for Study Reason for Study Date of Samples

kept for StudyLast station

Analyzed Observations

NA NA NA NA NA NA

QA Final Comments

Reviewed Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31



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9.2 Long Term Stability Studies:

Temperature/RH :





NA NA NA NA NA NA

QA Final Comments

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:42:14 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:42:14 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31

9.3 Intermediate Stability Studies:

Temperature/RH :





NA NA NA NA NA NA

QA Final Comments

Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On



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:05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31



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10.0 REVIEW OF CUSTOMER COMPLAINTS,RETURNED GOODS & RECALLS:

10.1 Summary of Customer Complaints:

S.No Date of Reciept

Customer Name

Complaint No. Batch No. Description of

Complaint

Date of Complaint

ClosureConclusion

NA NA NA NA NA NA NA NA

QA Final Comments

Total no. of complains received during this review period:NIL No. of complaint investigation closed:NIL No. of investigation open:NIL No. of complaints of previous review period closed in this review period: 0 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32

10.2 Summary of Returned Goods:

S.No Date of Receipt

Customer Name Report No. Batch No. Reason for

Return

Action Proposed/

Taken


NA NA NA NA NA NA NA NA



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QA Final Comments

No. of returns goods notification received during this review period:NIL No. of return goods notification closed:NIL No. of return goods notification open:NIL No. of batches returned during this review period:NIL Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32

10.3 Summary of Recalls:

S.No. Date of Initiation

Customer Name Report No. Batch No. Reason for

RecallAction

Proposed/Take nCurrent Status

of Closure

1 16.10.2015Sample

customer for testing

1234 ADIH000198

RECALL-SAMPLE

FOR TESTING

NA NA

QA Final Comments

Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On



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:06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32



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11.0 REVIEW OF PROCESS VALIDATION ACTIVITIES:

11.1 Summary of Process Validation:

S.No.Date of

Protocol Approval

Validation Protocol No.

Type of Validation

Reason for Validation

Validation Batch No.(s)

Current Status of

Study

NA NA NA NA NA NA NA

QA Final Comments

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38

11.2 Summary of Cleaning validation:

S.No. Date of Approval Protocol

Validation Protocol No. Reason for Validation Validation Batch No.

(s)Current Status of

Study

NA NA NA NA NA NA

QA Final Comments



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Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38

ANNUAL REVIEW REPORT-PRODUCT


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12.0 REVIEW OF REGULATORY FILING STATUS:

12.1 Summary on Regulatory Filing:

S.No Date of Filing Name of Regulatory Filing Type of Filing Currrent Status of File

1 10, 2015 Sample for testing Updation Active

QA Final Comments




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13.0 REVIEW OF RESERVE SAMPLES (FINISHED PRODUCT):

S.No. Batch No. Date of

ManufacturingDate of

Observation Description Sample pack Integrity Remarks


QA Final Comments




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14.0 REVIEW OF QUALITY TRENDS OF API STARTING MATERIAL:

Quality Trend of


S.No. Batch No.

QA FINAL COMMENTS



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15.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF INTERMEDIATE STAGES(S) OF PRODUCT:

Product Stage Code :

BPR Ref.No.

S.No Batch No. Incident No. Date of Incident

Description of the Incident

Status of Incident Investigation Batch Status


QA Final Comments



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16.0 REVIEW OF QUALITY TRENDS OF INTERMEDIATE STAGES(S) OF PRODUCT:

Quality Trend of


Scale

Validation Form No.

S.No. Batch No.

QA FINAL COMMENTS



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17.0 REVIEW OF YIELD TRENDS OF INTERMEDIATE STAGES OF PRODUCT:

Product Stage Code

BPR Ref.No. (Current Version):

S.No. Batch No.

Yield Results

Average

Standard Deviation

+3 Sigma limit

-3 Sigma limit

Details of Yield deviation batches:

S.No. Batch No. Incident No. Date of Incident Description of the Incident

Status of the Incident Investigation Batch Status


QA Final Comments:



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18.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF FINISHED STAGES(S) OF PRODUCT:

200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of

BPR Ref.No.

S.No Batch No. Incident No. Date of Incident

Description of the Incident

Status of Incident Investigation Batch Status


QA Final Comments



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19.0 REVIEW OF QUALITY TRENDS OF FINISHED STAGES(S) OF PRODUCT:

19.1.1 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of

S-08-OI-Ph.Eur/01Specification Ref. No.

20.00Scale

NOT APPLICABLEValidation Form No.

S.No. Batch No.

Appearance ( LIMIT: Yellow, crystalline powder.)

Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))

Identification by IR ( LIMIT: To match with working standard)

Sulphated ash ( Limit: NMT 0.1 %w/w )

Water ( Limit: NMT 1.0 %w/w )

Heavy metals ( LIMIT: Not more than 10 ppm)

Melting Point( Limit: Between188.0 and 194.0 °C )

Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )

1 ADHH003195Yellow,

crystalline powder.

Complies Complies

0.03 0.2 Less than 10 ppm

192.0 100.5

2 ADHH003163Yellow,

crystalline powder.

Complies Complies


191.7 99.9

3 ADHH003162Yellow,

crystalline powder.

Complies Complies


192.1 99.2

4 ADHH003914Yellow,

crystalline powder.

Complies Complies


192.6 100.2



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S.No. Batch No.









5 ADHH003860Yellow,

crystalline powder.

Complies Complies


193.7 100.3

6 ADHH003859Yellow,

crystalline powder.

Complies Complies


192.4 100.9

7 ADHH003857Yellow,

crystalline powder.

Complies Complies


192.5 100.5

8 ADHH003856Yellow,

crystalline powder.

Complies Complies


191.2 100.2

9 ADHH003855Yellow,

crystalline powder.

Complies Complies


192.5 100.2

10 ADHH003849Yellow,

crystalline powder.

Complies Complies


193.1 99.9


crystalline powder.

Complies Complies


192.2 99.4



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S.No. Batch No.










crystalline powder.

Complies Complies


191.9 99.4


crystalline powder.

Complies Complies


191.1 99.8


crystalline powder.

Complies Complies


192.1 100.1


crystalline powder.

Complies Complies


191.2 99.5


crystalline powder.

Complies Complies


191.4 99.4


crystalline powder.

Complies Complies


191.2 99.3


crystalline powder.

Complies Complies


191.7 99.4



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S.No. Batch No.









19 ADIH000528Yellow,

crystalline powder.

Complies Complies


190.2 100.1


crystalline powder.

Complies Complies


191.1 99.8


crystalline powder.

Complies Complies


191.9 99.5


crystalline powder.

Complies Complies


191.6 100.3


crystalline powder.

Complies Complies


192.2 100.2


crystalline powder.

Complies Complies


191.9 99.4


crystalline powder.

Complies Complies


191.2 99.1



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S.No. Batch No.










crystalline powder.

Complies Complies


190.2 99.2


crystalline powder.

Complies Complies


191.9 99.7


crystalline powder.

Complies Complies


191.8 99.8


crystalline powder.

Complies Complies


191.8 99.5


crystalline powder.

Complies Complies


191.7 100.0


crystalline powder.

Complies Complies


191.0 99.9


crystalline powder.

Complies Complies


191.2 99.8



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S.No. Batch No.










crystalline powder.

Complies Complies


192.9 99.5


crystalline powder.

Complies Complies


192.2 99.6


crystalline powder.

Complies Complies


191.3 100.0


crystalline powder.

Complies Complies


191.8 100.1


crystalline powder.

Complies Complies


191.2 100.5


crystalline powder.

Complies Complies


192.0 100.2


crystalline powder.

Complies Complies


192.0 99.9



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S.No. Batch No.










crystalline powder.

Complies Complies


191.0 99.9


crystalline powder.

Complies Complies


191.0 99.7


crystalline powder.

Complies Complies


191.3 99.4


crystalline powder.

Complies Complies


191.4 99.5


crystalline powder.

Complies Complies


191.4 99.8


crystalline powder.

Complies Complies


191.9 99.2


crystalline powder.

Complies Complies


191.3 100.2



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S.No. Batch No.










crystalline powder.

Complies Complies


192.2 100.1


crystalline powder.

Complies Complies


192.6 98.5


crystalline powder.

Complies Complies


191.8 99.8


crystalline powder.

Complies Complies


191.9 99.6


crystalline powder.

Complies Complies


191.8 99.1


crystalline powder.

Complies Complies


191.2 99.7


crystalline powder.

Complies Complies


191.9 99.9



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S.No. Batch No.










crystalline powder.

Complies Complies


192.1 99.6


crystalline powder.

Complies Complies


190.1 99.7


crystalline powder.

Complies Complies


192.5 99.8


crystalline powder.

Complies Complies


191.8 99.7


crystalline powder.

Complies Complies


191.9 99.9


crystalline powder.

Complies Complies


192.2 100.4


crystalline powder.

Complies Complies


191.0 99.3



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S.No. Batch No.










crystalline powder.

Complies Complies


192.0 99.6


crystalline powder.

Complies Complies


191.8 99.4


crystalline powder.

Complies Complies


191.4 99.3


crystalline powder.

Complies Complies


192.1 99.5


crystalline powder.

Complies Complies


192.0 98.6


crystalline powder.

Complies Complies


191.8 99.4


crystalline powder.

Complies Complies


191.9 99.7



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S.No. Batch No.










crystalline powder.

Complies Complies


192.5 99.3


crystalline powder.

Complies Complies


191.3 99.4


crystalline powder.

Complies Complies


191.3 99.4


crystalline powder.

Complies Complies


191.0 99.9


crystalline powder.

Complies Complies


190.6 99.8


crystalline powder.

Complies Complies


191.7 99.0


crystalline powder.

Complies Complies


191.9 99.3



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S.No. Batch No.










crystalline powder.

Complies Complies


191.5 99.8


crystalline powder.

Complies Complies


191.7 99.3


crystalline powder.

Complies Complies


190.6 100.4


crystalline powder.

Complies Complies


192.1 99.9


crystalline powder.

Complies Complies


191.7 99.4


crystalline powder.

Complies Complies


192.0 100.1

MEAN-BY SYSTEM NA NA NA 0.0199 0.1803 NA 191.7113 99.7188

SIGMA-BY SYSTEM NA NA NA 0.0100 0.1217 NA 0.6238 0.4329



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+3 SIGMA-BY SYSTEM NA NA NA 0.0499 0.5454 NA 193.5827 101.0175

-3 SIGMA-BY SYSTEM NA NA NA -0.0101 -0.1848 NA 189.8399 98.4201

S.No. Batch No.

Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )






Related Substances by HPLC ( Limit: NMT 0.2 % )


1 ADHH003195 Not detected 0.07 Not detected Not detected Not detected Not detected

0.12Less than LOQ (LOQ:0.009%)


0.13 Not detected


0.13 Not detected


0.12 Not detected


0.13 Not detected




0.13 Not detected


0.13 Not detected


0.12 Not detected



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S.No. Batch No.












0.1 Not detected


0.10 Not detected


0.12 Not detected


0.07 Not detected


0.08 Not detected


0.12 Not detected


0.12 Not detected


0.12 Not detected

19 ADIH000528 Not detected 0.07 Not detected Not detected Not detected

Below disregarding

limit(BDL:0.05%)

0.12 Not detected



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S.No. Batch No.









20 ADIH001405 Not detected 0.08 Not detected Not detected Not detected Not detected

0.13

Below limit of detection

(LOD:0.002%)

21 ADIH001358 Not detected 0.07 Not detected

0.01 Not detectedBelow

disregard limit(BLD:0.05%)

0.12

Less than LOQ(LOQ:0.009%)

22 ADIH001357 Notdetected 0.08 Notdetected Notdetected Notdetected Notdetected

0.11 Notdetected


0.12 Notdetected


0.10 Not detected


0.09 Not detected

26 ADIH000005 0.01 0.07 Not detected Not detected Not detected Not detected

0.13 Not detected


0.11 Not detected


0.10 Not detected


0.11 Not detected



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S.No. Batch No.










0.10 Not detected


0.12 Not detected


0.13 Not detected


0.11 Not detected


0.10 Not detected


0.10 Not detected


0.10 Not detected


0.12 Not detected


0.12 Not detected


0.11 Not detected


0.10 Not detected



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S.No. Batch No.









41 ADHH003527 Not detected 0.07 Not detected Not detected Not detected 0.06

0.17 Not detected


0.1 Not detected


0.1 Not detected







47 ADIH001275 Not detected 0.07 Not detected Not detected Not detected 0.07

0.19 Not detected


0.16 Not detected

49 ADIH000942 Notdetected 0.08 Notdetected Notdetected Notdetected

Below disregarding

limit(BDL:0.05%)

0.13 Notdetected


0.14 Not detected



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S.No. Batch No.










0.11 Not detected


Below disregarding

limit(BDL:0.05%)

0.12 Not detected


Below disregarding

limit(BDL:0.05%)

0.13 Not detected


0.12


(LOD:0.002%)


0.12


(LOD:0.002%)

56 ADIH000989 Not detected 0.06 Not detected Not detected Not detectedBelow

disregard limit(BDL:0.05%)

0.11



Below disregarding

limit(BDL:0.05%)

0.12 Notdetected


disregarding limit (0.05%)

0.13

Less than LOQ (LOQ:0.009%)



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S.No. Batch No.










disregard limit(BDL0.05%)

0.11



Below disregarding

limit(BDL:0.05%)

0.12



Below disregarding

limit (BDL:0.05%)

0.14 Not detected


Below Disregarding

Limit(BDL:0.05%)

0.13 Not detected


0.11


(LOD:0.002%)


0.11


(LOD:0.002%)


Below disregarding

limit(BDL:0.05%)

0.14 Notdetected


0.16Less than LOQ(LOQ:0.009%)



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S.No. Batch No.









67 ADIH000580 Not detected 0.08 Not detected Not detected 0.03

Below disregarding

limit (BDL:0.05%)

0.16 Not detected


0.11


(LOD:0.002%)

69 ADIH000796 Less than LOQ(LOQ:0.003%)

0.07 Not detected Not detected Not detected Not detected

0.11


(LOD:0.002%)


0.13


(LOD:0.002%)


0.14 Not detected


0.14 Not detected


disregard limit(BDL:0.05%)

0.12 Not detected


Below disregarding

limit (BDL:0.05%)

0.13 Not detected



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S.No. Batch No.










Below disregarding

limit (BDL:0.05%)

0.15 Not detected


Below disregarding

limit(BDL:0.05%)

0.12 Not detected


0.14 Not detected


0.13 Not detected


0.11 Not detected


0.12 Not detected

MEAN-BY SYSTEM 0.0001 0.0744 0.0000 0.0001 0.0004 0.0016 0.1213 0.0000

SIGMA-BY SYSTEM 0.0000 0.0100 0.0000 0.0000 0.0000 0.0100 0.0200 0.0000

+3 SIGMA-BY SYSTEM

0.0001 0.1044 0.0000 0.0001 0.0004 0.0316 0.1813 0.0000

-3 SIGMA-BY SYSTEM

0.0001 0.0444 0.0000 0.0001 0.0004 -0.0284 0.0613 0.0000



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S.No. Batch No.



Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )

Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )

Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )

Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )

Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )

Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )

1 ADHH003195 0.04 Less than LOQ (LOQ:0.008%)

Not detected

Less than LOQ

(LOQ:135.9ppm)

Not detected Not detected Not detected Not detected

2 ADHH003163 0.05 Not detected Not detected

Less than LOQ

(LOQ:135.9ppm)



137 Not detected Not detected Not detected Not detected




183 Not detected Not detected Not detected

Less than LOQ (LOQ:32.1ppm)


Not detected



Not detected



Not detected




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S.No. Batch No.










Not detected



Not detected



148 Not detectedLess than LOQ (LOQ:112.5pp

m)

Not detected Not detected


Less than LOQ

(LOQ:135.9ppm)




m)










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S.No. Batch No.










Less than LOQ

(LOQ:135.9ppm)




19 ADIH000528 0.05 Not detected Not detected

164 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)

20 ADIH001405 0.04 Less than LOQ(LOQ:0.008%)

Not detected


21 ADIH001358 0.04Below limit of

detection(LOD:0.002%)

Not detected



(LOD:9.6ppm)

22 ADIH001357 0.03 Notdetected Notdetected

136 Notdetected Notdetected Notdetected


(LOD:9.6ppm)


Less than LOQ

(LOQ:135.9ppm)


(LOD:40.3ppm)


(LOD:33.8ppm)

Notdetected


(LOD:9.6ppm)



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S.No. Batch No.










Less than LOQ

(LOQ:135.9ppm)



Less than LOQ

(LOQ:135.9ppm)



Less than LOQ

(LOQ:135.9ppm)




28 ADHH003941 0.04 Not detected Not detected Not detected 193 Not detected Not detected Not detected









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S.No. Batch No.












Less than LOQ

(LOQ:135.9ppm)









Less than LOQ

(LOQ:135.9ppm)





Less than LOQ

(LOQ:135.9ppm)

Not detectedLess than LOQ (LOQ:112.5pp

m)




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S.No. Batch No.















m)%)









Less than LOQ

(LOQ:135.9ppm)



143 Not detected


(LOD:33.8ppm)




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S.No. Batch No.










158 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


168 NotdetectedLess than LOQ(LOQ:112.5pp

m)

Notdetected Notdetected


144 Not detected


(LOD:33.8ppm)




Not detected

153 Not detected


(LOD:33.8 ppm)



147 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


262 Not detected 120 Not detected

Less than LOQ(LOQ:32.1ppm)


213 Notdetected


(LOD:33.8ppm)

Notdetected


(LOD:9.6ppm)



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S.No. Batch No.











Not detected

180 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


Less than LOQ

(LOQ:135.9ppm)


(LOD:40.3ppm)


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


Less than LOQ

(LOQ:135.9ppm)


(LOD:40.3ppm)Notdetected Notdetecte

d


(LOD:9.6ppm)


159 Not detected

Below limit of detection(LOD:

33.8ppm)

Not detected


9.6ppm)


160 Not detectedLess than LOQ(LOQ:112.5pp

m)



176 NotdetectedLess than LOQ(LOQ:112.5pp

m)






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S.No. Batch No.










Less than LOQ

(LOQ:135.9ppm)


(LOD:40.3ppm)Not detected Not

detected


(LOD:9.6ppm)


Less than LOQ

(LOQ:135.9ppm)




Not detected

Less than LOQ

(LOQ:135.9ppm)



145 Notdetected Notdetected Notdetected Notdetected



Not detected

Less than LOQ

(LOQ:135.9ppm)


67 ADIH000580 0.05 Not detected


(LOD:17.8ppm)

205


(LOD:40.3ppm) 130 Not

detected


(LOD:9.6ppm)



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S.No. Batch No.










Not detected

Less than LOQ

(LOQ:135.9ppm)



Less than LOQ

(LOQ:135.9ppm)




Not detected

207 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)




(LOD:9.6ppm)




166


(LOD:40.3ppm)Not detected Not

detected


(LOD:9.6ppm)


Less than LOQ

(LOQ:135.9 ppm)




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S.No. Batch No.










Less than LOQ

(LOQ:59.1ppm)

197


(LOD:40.3ppm)

Less than LOQ(LOQ:112.5pp

m)

Not detected

Less than LOQ(LOQ:32.1ppm)


Less than LOQ

(LOQ:59.1 ppm)

225

Less than LOQ (LOQ:133.4

ppm)) 117 Not

detectedLess than LOQ

(LOQ:32.1 ppm)



Not detected





164


(LOD:40.3ppm)


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


175 Not detected


33.8ppm)

Not detected


9.6ppm)

MEAN-BY SYSTEM 0.0430 0.0000 0.0000 125.4750 2.4125 4.5875 0.0000 0.0000

SIGMA-BY SYSTEM 0.0100 0.0000 0.0000 83.1066 21.5781 23.4130 0.0000 0.0000



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+3 SIGMA-BY SYSTEM

0.0730 0.0000 0.0000 374.7948 67.1468 74.8265 0.0000 0.0000

-3 SIGMA-BY SYSTEM

0.0130 0.0000 0.0000 -123.8448 -62.3218 -65.6515 0.0000 0.0000

S.No. Batch No.

Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )


Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )

XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha

*Particle size by Laser diffraction (Limit: NLT 100.0 % )



*Tapped density ( LIMIT:)

1 ADHH003195 450 Not detected Not detected Complies 100 100

100 0.61

2 ADHH003163 Not detected Not detected Not detected Complies 100 100

100 0.57


100 0.54


99 0.58


99 0.58


100 0.65



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S.No. Batch No.










100 0.64


97 0.57


100 0.53


100 0.60


100 0.57


99 0.63


100 0.55


99 0.59


94 0.64



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S.No. Batch No.










100 0.62


100 0.60


100 0.57

19 ADIH000528 190 Not detected Not detected Complies 100 100

100 0.62


89 0.60

21 ADIH001358Less than LOQ(LOQ:147.7pp

m)Not detected Not detected Complies 100 100

99 0.59

22 ADIH001357Below limit of

detection(LOD:44.4ppm)

Notdetected Notdetected Complies 100 100

99 0.57



Notdetected Notdetected Complies 100 100

99 0.55



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S.No. Batch No.









24 ADIH000037Less than LOQ (LOQ:147.7pp


100 0.64



100 0.64



100 0.63

27 ADHH003942Less than LOQ (LOQ:147.7pp


100 0.62


100 0.62


100 0.60



99 0.62



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S.No. Batch No.











96 0.55

32 ADIH000527 Not detected Not detected Not detected Complies 100 100

100 0.54


100 0.58


100 0.58


100 0.63


100 0.62


100 0.58


100 0.60



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S.No. Batch No.










100 0.64


99 0.59

41 ADHH003527 332 Not detected Not detected Does not comply 100 100

100 0.59


100 0.61


98 0.58


100 0.63

45 ADHH003240Less than LOQ (LOQ:147.7PP


100 0.66



100 0.54



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S.No. Batch No.











Not detected Not detected Complies 99 98

94 0.56



96 0.55


m)Notdetected Notdetected Complies 100 100

100 0.55



100 0.56


100 0.58


100 0.58

53 ADIH000579 251 Less than LOQ(LOQ:56.5ppm)

Not detected Complies 100 100

99 0.65

54 ADIH000905 Notdetected Notdetected Notdetected Complies 100 100

100 0.56



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S.No. Batch No.










99 0.58


100 0.59


97 0.57



100 0.58



100 0.57


m)Notdetected Notdetected Complies 100 100

100 0.56


97 0.58


98 0.58



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S.No. Batch No.










100 0.58


100 0.51


99 0.59


99 0.54



99 0.60


99 0.57


98 0.55


100 0.56



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S.No. Batch No.









71 ADIH000664 264 Not detected Not detected Does not comply 100 100

100 0.62


100 0.60


99 0.56


98 0.57


100 0.59


100 0.62


98 0.55


99 0.60



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S.No. Batch No.












95 0.59

80 ADIH001194Below limit of detection(LOD:

44.4ppm)Not detected Not detected Complies 100 100

100 0.55

MEAN-BY SYSTEM 50.3625 0.0000 0.0000 NA 99.9750 99.9500 99.1000 0.5876

SIGMA-BY SYSTEM 123.5218 0.0000 0.0000 NA 0.1572 0.3142 1.7761 0.0316

+3 SIGMA-BY SYSTEM

420.9279 0.0000 0.0000 NA 100.4466 100.8926 104.4283 0.6824

-3 SIGMA-BY SYSTEM

-320.2029 0.0000 0.0000 NA 99.5034 99.0074 93.7717 0.4928

QA FINAL COMMENTS

Total no. of batches analyzed during the review period: 80 No. ofbatches approved during the review period: 74 No. of batches rejectedduring this review period: 6 No. of batches falling outside +3Sigma: 0



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No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 50.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 90.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Tapped density (LIMIT:):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,



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ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Assay by HPLC (Onanhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Melting Point( Limit:Between188.0 and 194.0 °C):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC (Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC(Method-1) ( Limit: NMT 0.1 %):ADIH000005,ADIH000580,ADIH001358 Related Substances by HPLC(Method-1) ( Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,



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ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Created By :HP -Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:52:02 okreviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 05/10/2015 at 21:52:02 reviewed Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:35:08 OkReviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 12/10/2015 at 14:43:43 ssss Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 12/10/2015 at16:47:04 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:08:11 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:08:33 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:28:50 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :



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21/10/2015 at20:27:18 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:34:28 stested by pandu Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:16:35 SSSSSast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:05:09


S-08-OI-Ph.Eur/02Specification Ref. No.

20.00Scale


S.No. Batch No.









1 ADIH001663Yellow,

crystalline powder.

Complies Complies


192.2 100.2

2 ADIH001640Yellow,

crystalline powder.

Complies Complies


192.1 100.1



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S.No. Batch No.









3 ADIH001193Yellow,

crystalline powder.

Complies Complies


191.8 99.5

4 ADIH001584Yellow,

crystalline powder.

Complies Complies


191.2 100.1

5 ADIH001583Yellow,

crystalline powder.

Complies Complies


190.7 100.5

6 ADIH001884Yellow,

crystalline powder.

Complies Complies


191.5 100.3

7 ADIH001910Yellow,

crystalline powder.

Complies Complies


190.1 100.9

8 ADIH001911Yellow,

crystalline powder.

Complies Complies


192.8 99.3

9 ADIH001935Yellow,

crystalline powder.

Complies Complies


191.2 99.8



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S.No. Batch No.










crystalline powder.

Complies Complies


191.9 99.0


crystalline powder.

Complies Complies


192.2 100.3


crystalline powder.

Complies Complies


190.9 99.0


crystalline powder.

Complies Complies


191.9 99.3


crystalline powder.

Complies Complies


190.2 99.1


crystalline powder.

Complies Complies


191.2 99.7


crystalline powder.

Complies Complies


193.0 100.1



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S.No. Batch No.










crystalline powder.

Complies Complies


191.4 100.1


crystalline powder.

Complies Complies


192.0 100.0


crystalline powder.

Complies Complies


191.9 100.0


crystalline powder.

Complies Complies


192.1 99.8


crystalline powder.

Complies Complies


192.4 99.7


crystalline powder.

Complies Complies


190.3 99.8


crystalline powder.

Complies Complies


190.7 101.3



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S.No. Batch No.










crystalline powder.

Complies Complies


192.1 100.0


crystalline powder.

Complies Complies


189.9 99.8


crystalline powder.

Complies Complies


191.7 100.5


crystalline powder.

Complies Complies


191.4 99.3


crystalline powder.

Complies Complies


191.3 99.8


crystalline powder.

Complies Complies


192.2 100.4


crystalline powder.

Complies Complies


192.1 100.1



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MEAN-BY SYSTEM NA NA NA 0.0200 0.1163 NA 191.5467 99.9267

SIGMA-BY SYSTEM NA NA NA 0.0100 0.0436 NA 0.7895 0.5310

+3 SIGMA-BY SYSTEM NA NA NA 0.0500 0.2471 NA 193.9152 101.5197

-3 SIGMA-BY SYSTEM NA NA NA -0.0100 -0.0145 NA 189.1782 98.3337

S.No. Batch No.










disregard limit (BDL:0.05%)

0.12 Not detected


Below disregarding

limit(BDL:0.05%)

0.12


(LOD:0.002%)


Less than LOQ

(LOQ:0.004%)

Not detectedBelow

Disregard limit(BDL:0.05%)

0.13 Not detected


0.09 Notdetected


0.11 Not detected



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S.No. Batch No.










detection (LOD:0.0007%)

0.08

Less than LOQ

(LOQ:0.011 %)


Below disregarding

limit (BDL:0.05%)

0.11 Not detected


Detection(LOD:0.0007%)

0.07

Less than LOQ

(LOQ:0.011%)

Not detected Not detectedBelow


0.10 Not detected




0.12 Not detected

9 ADIH001935 Not detected 0.07 Not detectedLess than

LOQ(LOQ: 0.004%)

Not detected

Below disregarding

limit (BDL:0.05%)

0.09 Not detected


Below limit of Detection(LOD:0.004

%)

Not detectedBelow


0.10 Not detected



0.07

Less than LOQ

(LOQ:0.011 %)


Below disregarding

limit (BDL:0.05%)

0.10 Not detected

12 ADIH001882 Less than LOQ (LOQ:0.003 %)

0.07

Less than LOQ

(LOQ:0.011 %)


Below disregarding

limit (BDL:0.05%)

0.11 Not detected



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S.No. Batch No.











0.12

Below limit of Detection

(LOD:0.002%)


0.10


(LOD:0.002%)


Less than LOQ

(LOQ:0.004 %)


0.12 Not detected




Below disregarding

limit (BDL:0.05%)

0.1 Not detected


Below disregarding

limit (BDL:0.05%)

0.11 Not detected


0.11


(LOD:0.002%)



0.10 Not detected



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S.No. Batch No.










Below disregarding

limit (BDL:0.05%)

0.12 Not detected




0.11 Not detected


0.14 Not detected


0.14 Not detected



0.10 Not detected


0.11 Not detected


0.10 Not detected

28 ADIH001580 Not detected 0.09 Not detected Not detected Not detected 0.06

0.15 Not detected


0.12 Not detected


0.13 Not detected



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MEAN-BY SYSTEM 0.0000 0.0793 0.0000 0.0005 0.0000 0.0020 0.1133 0.0000

SIGMA-BY SYSTEM 0.0000 0.0100 0.0000 0.0000 0.0000 0.0100 0.0141 0.0000

+3 SIGMA-BY SYSTEM

0.0000 0.1093 0.0000 0.0005 0.0000 0.0320 0.1556 0.0000

-3 SIGMA-BY SYSTEM

0.0000 0.0493 0.0000 0.0005 0.0000 -0.0280 0.0710 0.0000

S.No. Batch No.











Not detected

Less than LOQ

(LOQ:135.9ppm)

Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)



Notdetected

152 Notdetected


(LOD:33.8ppm)



181 Not detected

Below Limit of Detection

(BLD:33.8ppm)

Not detected


(BLD:9.6ppm)



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S.No. Batch No.











Notdetected

149 Notdetected


(LOD:33.8ppm)

Notdetected


(LOD:9.6ppm)



Not detected

Less than LOQ

(LOQ:135.9ppm)


6 ADIH001884 0.02 Less than LOQ (LOQ:0.008%)

Not detected

191 Not detected 276 Not detected Not detected


Not detected

151 Not detected 214 Not detected Not detected


Not detected

139 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)

9 ADIH001935 0.02 Less than LOQ(LOQ: 0.008%)

Not detectedLess than

LOQ(LOQ: 135.9ppm)

Not detected


(LOD:33.8ppm)



Less than LOQ

(LOQ:135.9ppm)




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S.No. Batch No.











Not detected


m)



Not detected

184 Not detected 107 Not detected


(LOD:9.6ppm)


153 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)



Not detected

Less than LOQ

(LOQ:135.9ppm)

Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)



Not detected

156 Not detected


(LOD:33.8ppm)



Not detected

133 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)



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S.No. Batch No.










Less than LOQ

(LOQ:59.1ppm)

167 Not detected


(LOD:10ppm)



Less than LOQ

(LOQ:59.1ppm)

140 Not detected Not detected Not

detected Not detected



Not detected

Less than LOQ

(LOQ:135.9ppm)

Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


159 Not detected


(LOD:33.8ppm)



153 Not detected


(LOD:33.8ppm)

Not detected

Below Limit of Detection(LOD:

9.6ppm)


142 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)



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S.No. Batch No.










Not detected

163 Not detected


(LOD:33.8ppm)

Not detected


(LOD:9.6ppm)


Not detected

153 Not detected


(LOD:33.8ppm)



Less than LOQ

(LOQ:135.9ppm)

Not detected


(LOD:33.8ppm)




Not detected

162 Not detected


(LOD:33.8 ppm)




141 Not detected


(LOD:33.8ppm)




138 Not detectedLess than LOQ(LOQ:112.5pp

m)




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S.No. Batch No.










200 Not detected


(LOD:33.8ppm)




MEAN-BY SYSTEM 0.0280 0.0000 0.0000 121.5667 0.0000 19.9000 0.0000 0.0000

SIGMA-BY SYSTEM 0.0141 0.0000 0.0000 69.9811 0.0000 64.7384 0.0000 0.0000

+3 SIGMA-BY SYSTEM

0.0703 0.0000 0.0000 331.5100 0.0000 214.1152 0.0000 0.0000

-3 SIGMA-BY SYSTEM

-0.0143 0.0000 0.0000 -88.3766 0.0000 -174.3152 0.0000 0.0000



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S.No. Batch No.










100 0.58

2 ADIH001640 177 Notdetected Notdetected Complies 100 100

100 0.56

3 ADIH001193Below Limit of

Detection(BLD:44.4ppm)


99 0.55

4 ADIH001584 174 Notdetected Notdetected Complies 100 100

98 0.63


99 0.59


100 0.55


100 0.54


100 0.54



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S.No. Batch No.










100 0.55


Detection(LOD:44.4ppm)


100 0.59


99 0.58


98 0.57


100 0.57




100 0.56


detection (LOD:44.4ppm)


100 0.54



100 0.60



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S.No. Batch No.









17 ADIH002007 Not detected Not detected


(LOD:100ppm)

Complies 100 100

100 0.52


Detection(LOD:44.4ppm)


100 0.60




100 0.56


462 Complies 100 100

100 0.58


100 0.60


100 0.64


98 0.61



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S.No. Batch No.











100 0.59


Less than LOQ

(LOQ:370ppm)

Complies 100 100

100 0.59

26 ADIH001475Less than LOQ(LOQ: 147.7

ppm)Not detected Not detected Complies 100 100

100 0.57


100 0.60


100 0.59


100 0.59


99 0.58

MEAN-BY SYSTEM 44.3333 0.0000 15.4000 NA 100.0000 100.0000 99.6667 0.5773



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+3 SIGMA-BY SYSTEM

293.0237 0.0000 268.4479 NA 100.0000 100.0000 101.6494 0.6568

-3 SIGMA-BY SYSTEM

-204.3571 0.0000 -237.6479 NA 100.0000 100.0000 97.6840 0.4978

QA FINAL COMMENTS

Total no. of batches analyzed during the review period: 30 No. ofbatches approved during the review period: 30 No. of batches rejectedduring this review period: 0 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 50.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 90.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Tapped density (LIMIT:):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Assay byHPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,



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ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Melting Point(Limit: Between188.0 and 194.0 °C):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC ( Limit: NMT 0.2 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC (Method-1) ( Limit: NMT 0.1 %):ADIH001724,ADIH001911 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:55:22 Ok reviewed ModifiedBy : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015at 21:55:22 reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 05/10/2015 at 22:37:54 Ok Reviewed Modified By : HP- Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:52:10 sss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:10:17 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:17:47 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:33:48 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :



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21/10/2015 at20:29:49 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:37:32 SSS Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:32:18ast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:34:11


S-08-OI/14Specification Ref. No.

20.00Scale


S.No. Batch No.

Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)

Solubility ( LIMIT: Freely soluble in chloroform)


Loss on drying ( Limit: NMT 0.5 %w/w )

Moisture Content ( Limit: NMT 0.5 %w/w )

Residue on ignition ( Limit: NMT 0.1 %w/w )


Melting point( Limit: Between188.0 and 194.0 °C )

1 ADIH000198Yellow colour

crystalline powder.

Complies Complies

0.3 0.1

0.03Less than 10

ppm 191.8


crystalline powder.

Complies Complies

0.2 0.09

0.02Less than 10

ppm 192.1


crystalline powder.

Complies Complies

0.2 0.08

0.03Less than 10

ppm 190.2


crystalline powder.

Complies Complies

0.2 0.05

0.01Less than 10

ppm 191.2



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S.No. Batch No.










crystalline powder.

Complies Complies

0.3 0.1

0.02Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.3 0.07

0.02Less than 10

ppm 190.9


crystalline powder.

Complies Complies

0.3 0.06

0.03Less than 10

ppm 192.0


crystalline powder.

Complies Complies

0.3 0.08

0.03Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.2 0.09

0.02Less than 10

ppm 192.1


crystalline powder.

Complies Complies

0.2 0.05

0.01Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.3 0.08

0.03Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.2 0.07

0.03Less than 10

ppm 190.6


crystalline powder.

Complies Complies

0.2 0.1

0.03Less than 10

ppm 191.5



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S.No. Batch No.









14 ADHH003943Yellow colour

crystalline powder.

Complies Complies

0.2 0.2

0.01Less than 10

ppm 191.8


crystalline powder.

Complies Complies

0.3 0.1

0.01Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.2 0.2

0.01Less than 10

ppm 191.8


crystalline powder.

Complies Complies

0.2 0.3

0.02Less than 10

ppm 191.7


crystalline powder.

Complies Complies

0.2 0.08

0.02Less than 10

ppm 190.9


crystalline powder.

Complies Complies

0.2 0.1

0.02Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.7


crystalline powder.

Complies Complies

0.2 0.3

0.01Less than 10

ppm 190.2


crystalline powder.

Complies Complies

0.2 0.0

0.02Less than 10

ppm 190.8



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S.No. Batch No.










crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.7


crystalline powder.

Complies Complies

0.2 0.07

0.02Less than 10

ppm 190.5


crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.2 0.1

0.04Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.2 0.1

0.01Less than 10

ppm 192.9


crystalline powder.

Complies Complies

0.2 0.2

0.01Less than 10

ppm 191.5


crystalline powder.

Complies Complies

0.2 0.1

0.04Less than 10

ppm 192.1


crystalline powder.

Complies Complies

0.2 0.1

0.04Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.2 0.1

0.01Less than 10

ppm 191.2



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S.No. Batch No.










crystalline powder.

Complies Complies

0.2 0.1

0.01Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.1

0.02Less than 10

ppm 192.4


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 192.9


crystalline powder.

Complies Complies

0.3 0.1

0.01Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 190.0


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.4


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.0


crystalline powder.

Complies Complies

0.3 0.06

0.02Less than 10

ppm 190.1


crystalline powder.

Complies Complies

0.2 0.1

0.01Less than 10

ppm 192.3



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S.No. Batch No.










crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 190.8


crystalline powder.

Complies Complies

0.3 0.3

0.01Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.3 0.1

0.04Less than 10

ppm 190.1


crystalline powder.

Complies Complies

0.2 0.1

0.03Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.0


crystalline powder.

Complies Complies

0.3 0.2

0.03Less than 10

ppm 190.2


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.6


crystalline powder.

Complies Complies

0.1 0.3

0.01Less than 10

ppm 190.5


crystalline powder.

Complies Complies

0.1 0.09

0.02Less than 10

ppm 189.5



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S.No. Batch No.










crystalline powder.

Complies Complies

0.2 0.1

0.02Less than 10

ppm 193.2


crystalline powder.

Complies Complies

0.3 0.2

0.02Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 191.7


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 190.2


crystalline powder.

Complies Complies

0.3 0.3

0.02Less than 10

ppm 190.2


crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.2 0.1

0.02Less than 10

ppm 191.1


crystalline powder.

Complies Complies

0.3 0.1

0.02Less than 10

ppm 191.1



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S.No. Batch No.










crystalline powder.

Complies Complies

0.2 0.3

0.01Less than 10

ppm 191.4


crystalline powder.

Complies Complies

0.2 0.09

0.01Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 190.7


crystalline powder.

Complies Complies

0.1 0.09

0.02Less than 10

ppm 191.7


crystalline powder.

Complies Complies

0.2 0.2

0.02Less than 10

ppm 191.5


crystalline powder.

Complies Complies

0.3 0.2

0.02Less than 10

ppm 189.9


crystalline powder.

Complies Complies

0.2 0.2

0.03Less than 10

ppm 190.8


crystalline powder.

Complies Complies

0.2 0.1

0.01Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.3 0.1

0.02Less than 10

ppm 189.9



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S.No. Batch No.










crystalline powder.

Complies Complies

0.3 0.1

0.02Less than 10

ppm 191.9


crystalline powder.

Complies Complies

0.3 0.2

0.01Less than 10

ppm 191.2


crystalline powder.

Complies Complies

0.3 0.2

0.02Less than 10

ppm 190.8


crystalline powder.

Complies Complies

0.3 0.1

0.03Less than 10

ppm 191.6

MEAN-BY SYSTEM NA NA NA 0.2254 0.1451 0.0208 NA 191.1817

SIGMA-BY SYSTEM NA NA NA 0.0529 0.0728 0.0100 NA 0.8323

+3 SIGMA-BY SYSTEM NA NA NA 0.3841 0.3635 0.0508 NA 193.6786

-3 SIGMA-BY SYSTEM NA NA NA 0.0667 -0.0733 -0.0092 NA 188.6848



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S.No. Batch No.

Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )

Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )

Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )

Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )

Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )

Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )

Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )

Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )

1 ADIH000198 Not detected 0.01 Not detected Not detected Less than LOQ(LOQ:0.020%)

Not detected Not detected 0.06





4 ADIH000227 Not detected Less than LOQ(LOQ:0.012%)

Not detected Not detected Not detected Not detected Not detected 0.07





7 ADIH000285 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.07







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S.No. Batch No.












14 ADHH003943 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08









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S.No. Batch No.





















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S.No. Batch No.











33 ADIH001664 Not detected Not detected Not detected Not detected Not detected Not detected Not detected 0.08


Not detected Not detectedBelow limit of




Not detected Not detectedBelow limit of



36 ADIH001333 Not detected 0.05 Not detected Not detectedBelow limit of







39 ADIH001418 Not detected Less than LOQ(LOQ: 0.012%)

Not detected Not detectedBelow Limit of Detection(LOD:

0.0054%)Not detected

Less than LOQ(LOQ: 0.0404%)

0.05



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S.No. Batch No.









40 ADIH001639 Not detected Not detected Not detected Not detected Not detected Not detected Not detected 0.07


















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S.No. Batch No.





















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S.No. Batch No.
























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S.No. Batch No.












MEAN-BY SYSTEM 0.0000 0.0445 0.0000 0.0000 0.0000 0.0000 0.0000 0.0804

SIGMA-BY SYSTEM 0.0000 0.0224 0.0000 0.0000 0.0000 0.0000 0.0000 0.0141

+3 SIGMA-BY SYSTEM

0.0000 0.1117 0.0000 0.0000 0.0000 0.0000 0.0000 0.1227

-3 SIGMA-BY SYSTEM

0.0000 -0.0227 0.0000 0.0000 0.0000 0.0000 0.0000 0.0381

S.No. Batch No.

Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )

Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )

Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )

XRD ( LIMIT: To match with working standard)


Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )



1 ADIH000198 0.01 0.09

99.9 Complies Not detected 153 Not detected Not detected



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S.No. Batch No.









2 ADIH000225 0.01 0.12


3 ADIH000226 0.01 0.14

99.2 Complies Not detectedLess than LOQ(LOQ:135.9pp

m)


4 ADIH000227 0.01 0.09


5 ADIH000271 0.02 0.12

99.3Does not comply Not detected 152 Not

detected


(LOD:33.8ppm)

6 ADIH000272 0.01 0.11


m)


7 ADIH000285 0.01 0.13


m)


8 ADIH000286 0.01 0.12


m)


9 ADIH000354 0.01 0.13


m)


10 ADIH000355 0.01 0.15




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S.No. Batch No.









11 ADIH000375 0.01 0.14


12 ADIH000376 0.01 0.14


13 ADIH000171 0.01 0.14


14 ADHH003943 0.01 0.14


m)


15 ADHH003989 0.01 0.16


16 ADHH004012 0.01 0.14


17 ADHH004013 0.01 0.13


m)


18 ADHH004014 0.01 0.14


19 ADHH004015 0.01 0.13


20 ADHH004016 0.01 0.13




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S.No. Batch No.









21 ADHH004041 0.01 0.14


m)


22 ADHH004061 Not detected 0.15


m)




m)


24 ADIH000038 Not detected 0.13




m)




27 ADIH000170 0.02 0.15


28 ADIH000197 0.02 0.12


29 ADIH001958 0.01 0.15


m)




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S.No. Batch No.









30 ADIH001959 0.01 0.14

100.0 Complies Not detected 138 Not detected


(LOD:33.8ppm)

31 ADIH001960 0.01 0.15


m)




m)


33 ADIH001664 0.01 0.09


m)

Not detected

Less than LOQ(LOQ:112.5ppm

)


100.0 Complies Not detected 177

Below limit of

detection(LOD:40.3

ppm)


(LOD:33.8ppm)



Below limit of

detection(LOD:40.3

ppm)


(LOD:33.8ppm)




(LOD:33.8ppm)



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S.No. Batch No.










99.8 Complies Not detectedLess than LOQ

(LOQ: 135.9ppm)




Below limit of

detection(LOD:40.3

ppm)

Not detected

39 ADIH001418 0.002 0.08



(LOD:33.8ppm)

40 ADIH001639 0.01 0.08


m)

Not detected


(LOD:33.8ppm)



m)

Not detected


(LOD:33.8ppm)

42 ADHH003544 0.01 0.14


43 ADHH003571 0.01 0.13


44 ADHH003586 0.01 0.14

100 Complies Not detected 143 Not detected Not detected



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S.No. Batch No.












(LOD:33.8ppm)




(LOD:33.8ppm)

47 ADHH003613 0.01 0.17


48 ADHH003614 0.01 0.19

99.3 Complies Not detectedLess than LOQ (LOQ:135.9pp

m)





(LOD:33.8ppm)

50 ADHH003667 0.02 0.16


51 ADHH003688 0.01 0.16


m)


52 ADIH000643 0.01 0.17


53 ADIH000642 0.01 0.18




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S.No. Batch No.













m)




m)




m)




m)










Less than LOQ (LOQ:112.5ppm

)



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S.No. Batch No.



















Below limit of

detection(LOD:40.3

ppm)

Not detected



m)





(LOD:33.8ppm)



m)

Not detected


(LOD:33.8ppm)

71 ADIH000172 0.01 0.14




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MEAN-BY SYSTEM 0.0059 0.1342 99.7042 NA 0.0000 100.5775 0.0000 0.0000


+3 SIGMA-BY SYSTEM

0.0059 0.2137 100.9207 NA 0.0000 336.9358 0.0000 0.0000

-3 SIGMA-BY SYSTEM

0.0059 0.0547 98.4877 NA 0.0000 -135.7808 0.0000 0.0000

S.No. Batch No.

Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )


Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )

Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )


**Particle size by Laser diffraction (Limit: NLT 100.0 % )




808 Not detected Not detected 100

100 97

2 ADIH000225 Not detected Not detected Not detected Not detected Not detected 100

100 100


100 100


100 100


659 Not detectedBelow limit of

detection(LOD:100ppm)

100

100 100



100 100



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S.No. Batch No.











100 100



100 100


100 100


100 100


Less than LOQ

(LOQ:147.7ppm)

Not detected Not detected 100

100 100


100 100


100 100

14 ADHH003943 Not detected Not detected

Less than LOQ

(LOQ:147.7ppm)


100 100



100 100



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S.No. Batch No.











100 100

17 ADHH004013 Not detected Not detected Not detected Not detected Not detected 100

100 100


Less than LOQ

(LOQ:147.7ppm)


100 100



100 100



100 99


100 100


Less than LOQ

(LOQ:147.7ppm)


100 100


100 100



100 100



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S.No. Batch No.










Less than LOQ

(LOQ:147.7ppm)


100 100



100 100


100 100



100 100



(LOD:44.4ppm)


100 100


Less than LOQ

(LOQ:147.7ppm)


100 100



(LOD:44.4ppm)


100 100



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S.No. Batch No.











(LOD:44.4ppm)


100 100

33 ADIH001664 Not detectedBelow limit of


Not detected Not detected Not detected 100

100 98




99 94




100 94




100 99

37 ADIH001359 Not detectedBelow Limit of Detection(LOD:

9.6ppm)


(LOD: 44.4ppm)


100 100


Less than LOQ

(LOQ:147.7ppm)


100 97



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S.No. Batch No.









39 ADIH001418 Not detectedBelow Limit of Detection(LOD:

9.6ppm)Not detected Not detected Not detected 100

100 100



100 99


100 100


100 100


100 100


100 100


100 100


100 100


100 100


100 100



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S.No. Batch No.










100 100



100 100


100 100


100 100



100 99


100 100


100 99


100 100


100 100



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S.No. Batch No.










Less than LOQ

(LOQ:147.7ppm)


100 99


100 100


100 100


100 99


Less than LOQ

(LOQ:147.7ppm)


100 99



100 100


100 100

65 ADHH003270 Not detected Less than LOQ (LOQ:32.1ppm)


100 100

66 ADHH003305 Not detected Less than LOQ (LOQ:32.1ppm)


100 100



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S.No. Batch No.











(LOD:44.4ppm)


100 97



(LOD:44.4ppm)


100 99



Less than LOQ

(LOQ:147.7ppm)


100 100


detection (LOD:9.6ppm)

Less than LOQ

(LOQ:147.7ppm)


100 87


100 100

MEAN-BY SYSTEM 0.0000 0.0000 90.3662 0.0000 0.0000 99.9859 99.9859 99.3662

SIGMA-BY SYSTEM 0.0000 0.0000 190.6236 0.0000 0.0000 0.1187 0.1187 1.8992

+3 SIGMA-BY SYSTEM

0.0000 0.0000 662.2370 0.0000 0.0000 100.3420 100.3420 105.0638



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-3 SIGMA-BY SYSTEM

0.0000 0.0000 -481.5046 0.0000 0.0000 99.6298 99.6298 93.6686

QA FINAL COMMENTS

Total no. of batches analyzed during the review period: 71 No. ofbatches approved during the review period: 69 No. of batches rejectedduring this review period: 2 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: **Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 50.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 90.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,



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ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Assay by HPLC (On dried basis)( Limit: Between98.0 and102.0 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Loss on drying ( Limit: NMT 0.5 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Melting point( Limit: Between188.0 and 194.0 °C):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Related Substances by HPLC : Any other Impurity ( Limit:NMT 0.1 %):ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960 Related Substances by HPLC : LIP-2 quarternary salt (Limit: NMT 0.2 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,



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ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:58:43 Reviewed Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at21:58:43 reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 05/10/2015 at 22:40:21 Ok Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:55:52 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 12/10/2015 at 14:56:10 ss Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at23:24:07 ss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:25:12 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:20:16 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:39:17 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :



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21/10/2015 at20:33:24 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 20:34:26 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at23:41:01SSSS PANDUast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:45:59


Name of Product :

ARR No.: Reviewed Period:


CTO UNIT-IV

LIP-3 (OLANZAPINE CANADIAN MKT)

October-2014 to October-2015PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229

172of148Page

20.0 REVIEW OF YIELD TRENDS OF API (FINISHED) STAGES OF PRODUCT:

20.1.1 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Product Stage Code

BPR Ref.No. (Current Version):

S.No. Batch No.

Yield Results

1 ADIH002009 9.300

2 ADIH002007 9.600

Average 9.45

Standard Deviation 0.21

+3 Sigma limit 10.08

-3 Sigma limit 8.82



Status of the Incident

InvestigationBatch Status


QA FINAL COMMENTS:


Name of Product :



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172of149Page

Total no. of batches manufactured during the review period:002 No. of batches failed to meet the Yield limits:002 No. of batches falling outside +3 Sigma:002 No. of batches falling outside -3 Sigma:000 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:41 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:16 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:31 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:42:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:01

20.1.2 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Product Stage Code

NOTAPPLICABLEBPR Ref.No. (Current Version):

S.No. Batch No.

Yield Results


Name of Product :



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172of150Page

S.No. Batch No.

Yield Results

Average 8.90

Standard Deviation 0.59

+3 Sigma limit 10.67

-3 Sigma limit 7.13



Status of the Incident

InvestigationBatch Status


QA FINAL COMMENTS:



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21.0 REVIEW OF LAST ARR

Date of Approval of Last Year's ARR:

Recommended Actionable Points from Last Year's ARR:

Status of CAPAs

S.No. Proposed CAPA Date of Completion of CAPA Status

NA NA NA NA

QA Final Comments

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:25 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:47:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:48:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:26:43 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:46:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:38



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Name of the Section Final Summary

REVIEW OF INCIDENTS

Total no. of incidents reported during this review period: 20 No. of incidents closed: 19 No. of incidenets open: 0 No. of incidents of previous rev period closed in this rev period: 0 No. of incidents of previous rev period still open in this rev period: 0 Total no. of CAPAs raised during the review period: 0 No. of CAPAs closed: 0 No. of CAPAs open: 0 No. of CAPAs that crossed timeline, but closed: 0 No. of overdue open CAPAs: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:28:08 great Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:28:08 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:21:25 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:02:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:55:07

REVIEW OF CHANGE CONTROLS

Total no. of change control inititated: 16 No. of change control closed: 7 No. of change control open: 9 No. of change control of previous rev. period closed in this 0 No. of change control of previous rev. period still open at 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:29:11 good Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:29:11 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:23:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:59



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Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:03:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:56:32

REVIEW OF ACCELERATED STABILITY MONITORING

PROGRAM

Reviewed Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31

REVIEW OF LONG TERM STABILITY MONITORING

PROGRAM

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:42:14 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:42:14 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :



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05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31

REVIEW OF INTERMEDIATE STABILITY MONITORING

PROGRAM

Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31

REVIEW OF CUSTOMER COMPLAINTS

Total no. of complains received during this review period:NIL No. of complaint investigation closed:NIL No. of investigation open:NIL No. of complaints of previous review period closed in this review period: 0 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03



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Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32

REVIEW OF RETURNED GOODS

No. of returns goods notification received during this review period:NIL No. of return goods notification closed:NIL No. of return goods notification open:NIL No. of batches returned during this review period:NIL Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32

REVIEW OF RECALLS

Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13



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REVIEW OF PROCESS VALIDATION ACTIVITIES

reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38

REVIEW OF CLEANING VALIDATION ACTIVITIES

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:45:28 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:45:28 reviewed



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REVIEW OF REGULATORY FILING STATUS

Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:47 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:56 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:30 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:30:52 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:59:27

REVIEW OF RETAINED SAMPLES (FINISHED

PRODUCT


REVIEW OF LAST ARR

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:25 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:47:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:48:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On



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:06/10/2015 at 11:26:43 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:46:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:38

REVIEW OF STARTING MATERIALS FROM NEW

SOURCE

Reviewed Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:07:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 15:59:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed



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REVIEW OF PACKAGING MATERIALS FROM NEW

SOURCE

Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:07:54 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 15:59:23 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35

REVIEW OF OOS RESULTS

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52

REVIEW OF OOT RESULTS

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 sss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52Reprocessed batch nos. that failed meeting specification: 0 ,ADIH001371



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REVIEW OF REPROCESS & REWORK

Reworked batch nos. that failed meeting specification: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:58 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:58 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:20:39 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:40 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:47 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:54:27Total no. of batches analyzed during the review period: 80 No. ofbatches approved during the review period: 74 No. of batches rejectedduring this review period: 6 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 50.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,



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ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 90.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Tapped density (LIMIT:):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,



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Quality Trend for Finished Material200001445_200001445_S

-08-OI-P

ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Assay by HPLC (Onanhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Melting Point( Limit:Between188.0 and 194.0 °C):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC (Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,



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ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC(Method-1) ( Limit: NMT 0.1 %):ADIH000005,ADIH000580,ADIH001358 Related Substances by HPLC(Method-1) ( Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Created By :HP -Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:52:02 okreviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 05/10/2015 at 21:52:02 reviewed Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:35:08



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OkReviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 12/10/2015 at 14:43:43 ssss Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 12/10/2015 at16:47:04 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:08:11 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:08:33 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:28:50 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:27:18 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:34:28 stested by pandu Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:16:35 SSSSSast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:05:09Total no. of batches analyzed during the review period: 30 No. ofbatches approved during the review period: 30 No. of batches rejectedduring this review period: 0 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 50.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,



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-08-OI-P

ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 90.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Tapped density (LIMIT:):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Assay byHPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Melting Point(Limit: Between188.0 and 194.0 °C):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC ( Limit: NMT 0.2 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC (Method-1) ( Limit: NMT 0.1 %):ADIH001724,ADIH001911 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:55:22



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Ok reviewed ModifiedBy : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015at 21:55:22 reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 05/10/2015 at 22:37:54 Ok Reviewed Modified By : HP- Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:52:10 sss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:10:17 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:17:47 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:33:48 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:29:49 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:37:32 SSS Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:32:18ast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:34:11Total no. of batches analyzed during the review period: 71 No. ofbatches approved during the review period: 69 No. of batches rejectedduring this review period: 2 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: **Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,



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ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 50.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 90.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Assay by HPLC (On dried basis)( Limit: Between98.0 and102.0 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,



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-08-OI/1

ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Loss on drying ( Limit: NMT 0.5 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Melting point( Limit: Between188.0 and 194.0 °C):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Related Substances by HPLC : Any other Impurity ( Limit:NMT 0.1 %):



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ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960 Related Substances by HPLC : LIP-2 quarternary salt (Limit: NMT 0.2 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:58:43 Reviewed Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at21:58:43 reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 05/10/2015 at 22:40:21 Ok Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:55:52 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 12/10/2015 at 14:56:10 ss Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at23:24:07 ss



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22.0 SUMMARY REPORT:


Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:25:12 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:20:16 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:39:17 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:33:24 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 20:34:26 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at23:41:01SSSS PANDUast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:45:59

Yield Trend for Finished Material200001445_200001445__

1004_2014

Total no. of batches manufactured during the review period:002 No. of batches failed to meet the Yield limits:002 No. of batches falling outside +3 Sigma:002 No. of batches falling outside -3 Sigma:000 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:41 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:16 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:31 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:42:41



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Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:01

Yield Trend for Finished Material200001445_200001445_N

OTAPPLICABSummary of CAPAs:

CAPAs raised during this review period i. Total no. of CAPAs raised: ii. No. of CAPAs closed: iii. No. of CAPAs open: iv. No. of closed CAPAs that crossed timeline: v. No. of overdue open CAPAs: CAPAs raised till date 0 ii. No. of CAPAs generated outside the current review period, but closed during iii. No. of CAPAs generated outside the current review period, but closed during the current rev. period that crossed timelines: Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:27:30 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:47:32 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:13:35



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23.1 Open Items:

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21

23.2 Comments:

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21

23.3 CONCLUSION AND RECOMMENDATIONS:

Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21

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