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Master Formula Master Formula And Batch And Batch

MaNUFACTURING MaNUFACTURING RecordRecord

Introduction:

MFR: Definition:

“An approved master document that describes the full process of manufacturing for the batch of specific product.”

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Definition:

According to various guidelines,

WHO

EU

Health Canada

US

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Different Names Of MFR:

MFR (INDIA)

MFPI(TGA , AUSTRALIA)

MMI AND MPI (MCC IN SA)

MFPI (WHO)

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A MFR is required for each batch and batchsize.

Definition of Batch:

It is single process or series of process.

Definition of Lot:

It is the final product in the final container.

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Instructions for the preparation of Instructions for the preparation of MFRMFR : :

Purpose

Objective

Scope

Responsibility   

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Procedure :

Master document include following:

 The name and reference code.

The proprietary name, generic name, strength ,

batch size of the product.

The expected final yield.

Processing instructions.

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Instructions for In-process controls.

Storage conditions.

Packing detail.

Abbreviations.

Copies to Distribution Sites. 

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Content of MPF (WHO):Name with reference code.

Description.

List of starting material.

Final yield.

Location.

Process instruction.

Storage.

Precaution.9

Contents of MPF (WHO):Contents of MPF (WHO): Name of the product.

Description.

Pack size.

Complete list of packaging material.

Relevant printed packaging materials &

Specimens.

Special precautions.

Description of the packaging operation.

Details of in-process controls with instructions. 10

Batch Processing & Control Record:Batch Processing & Control Record: Definition :

B.P.C.R. is primarily a replica of the M.P.C.R.,

additionally it gives the actual process record of the batch

produced and help in maintaining the complete production

and control history of the batch.

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Different Names of BPCR: BMR (INDIA)

BP and BPR (WHO)

BMR and BPR (MCC, SA)

BP and BPR (MHRA)

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BPCR are required to be maintained for each batch of product

manufactured.

These should be based on MFR.

Method of preparation of BPCR should be such that transcription

errors do not occur.

Before any process begins a check should be made to ensure that

all work stations are clear of previous product, material and

documents. This check should be recorded.

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Essential Components of a Batch Record:

Document Identification.

Company Name.

Dates of Manufacturing.

Product Identification.

A step by step account of the processing and

testing to be done.14

The monitoring specifications-how will the

operators know if the process is proceeding

properly.

Raw data must be collected and blanks must be

filled in with the information.

Materials and equipment used .

Signatures required.

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Batch Processing Records:

A batch processing record should be kept for each

batch processed.

It should be based on the relevant parts.

Before any processing begins, a check should be

made.

This check should be recorded.

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Content of BPR:Name , number of the batch being manufactured.

Dates and times.

Name of the person responsible.

Batch / lot number and the quantity of each

starting material actually weighed.

Relevant processing operation.

Amount of product obtained.

Notes on special problems.17

Batch Packaging Records:

A batch packaging record should be kept for each

batch or part batch processed.

Based on the relevant parts of the approved

packaging instructions.

Before any packaging operation begins, checks should

be made.

These checks should be recorded.18

Content of BPR: Name , batch number, quantity of bulk product.

Date and Time.

The name of the responsible person.

Identity.

Details of the packaging operations.

Batch number, expiry date, and any additional

overprinting

Special problems. 19

Basic Difference: B/W MPCR and Basic Difference: B/W MPCR and BPCR:-BPCR:-MPCR is the type of master document, means with

the help of MPCR only, the BPCR is prepared.

BPCR is unique batch wise, means all batches have

their individual BPCR.

Moreover BPCR contains ‘Date and Time’, that when

the batch was processed.

MPCR is the reference copy.20

Example of BMR:Name of product: Alerid Tablet Batch no.: Batch size:Date of Mfg commencement:Date of Mfg Completed:

Temperature: 0CHumidity: % Page No. 21

Sr. No.

Ingredient A.R. No. Quantity(Kg)

Weighed by

Checked by

Prepared Date & Timeby

Stage: Shifting or sievingName of product:Batch no.:

Date: Started on: Completed on:

Time:Temp.: 0C. Humidity: %.

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Sr. No.

Ingredient Equip-ment No.

Equip-ment cleaned by

Equip-ment checked by

Sieve no. #

Previous Product

Operat-or

Sign Of superv-iser

Stage: MixingName of product:Batch no.:

Time of mixing: Mins.Temperature: 0CHumidity: %

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Sr. No.

Ingredient AddedBy

Checkedby

Equip-ment No.

Equip-ment cleaned by

Equip-ment checked by

Previous Product

DateAndtime

Stage : DryingStage : Drying

Name of product:Batch no.:

Temperature: 0C Date & Time :Humidity: %

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Equip-ment No.

Previous Product

Inlet Temp.(0C)

Outlet Temp.(0C)

TimeOfDrying

IPQCL.O.D.

Operator CheckedBy

Stage: Milling Stage: Milling Name of product:Batch no.:

Practical Yield: %.Temperature: 0CHumidity: %.

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Equip-ment No.

Previous Product

MeshSize

Operator CheckedBy

DateAndTime

Stage: LubricationStage: LubricationName of product:Batch no.:

Temperature: 0CHumidity: %.

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Equip-ment No.

Previous Product

TimeOfBlending

Lubrica-ntAdded

LubricantAddedBy

CheckedBy

VerifyBy

DateAndTime

Stage: CompressionStage: Compression

Name of product:Batch no.:

Temperature: 0CHumidity: %.

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Equip-ment No.

Equip-ment cleaned by

Equip-ment checked by

Previous Product

SpeedOfMachine

WeighedBy

CheckedBy

DateAndTime

Stage: CoatingStage: CoatingName of product:Batch no.:

Temperature: 0CHumidity: %.

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Sr.No

Ingredient Equip-ment No.

Previous Product

Quantity A.RNo.

WeighedBy

CheckedBy

DateAndTime

Stage: Packaging

Name of product:Batch no.:

Temperature: 0CHumidity: %.

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DateOfPackaging

Equip-ment No.

Equip-ment cleaned by

Equipment checked by

LineClearance

CheckedBy

DateAndTime

Stage: StorageStage: Storage

Name of product:

Batch no.:

Date of completion:

Mfg date:

Exp date:

Temperature: 0C

Humidity: %.30

MF and corresponding Batch Records: MF give the complete production instructions.

Blank spaces are provided for the entry of data.

The BPR is the approved copy of the master document with

filled in data entries.

Once a final product has been produced, BR is comprised

of a single document.

The product is a pool of several intermediates or final bulks

then the full batch record includes the individual batch

records of all the components.31

Issuing of MF copy as a blank BR:

MF are almost invariably stored on the computer.

QA is responsible to generate a copy.

The MF should make reference to in process tests, QC

tests.

The batch record, however, includes the record sheets

of all the production records and support records.32

Master formulae, once approved and signed, should remain under the control of QA.

Master copies of the MF can be distributed to

relevant departments if needed.

There will obviously be company-by-company differences in the details of the procedures for QA approval and issuing of MF.

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Electronic MF and BR: The MF is invariably on the computer, and should be under

pass-word control of QA.

Photocopies – stamped, numbered, and on a distribution list -

may be issued as reference copies to the relevant department

head.

The electronic version may have the signature and date fields

typed in, e.g. "official copy signed by XXX”; “official copy

dated ddmmyy”.

If the electronic copy is printed out as the BBR for each

production run, the QA department must stamp each page of the

printout and sign that it is the approved current MF. 34

References :-References :-www.who.in

www.law.justia.com

www.ncbi.com

www.law.cornell.edu

www.cgmp.com

www.qualityassurancepharma.blogspot.com

Prof. Manohar A.Potdar,“Pharmaceutical Quality

Assurance,”by Nirali Prakashan Page no.7.7-7.1435

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