Prepared By : Amit $hah

M.Pharm Q.A

RAW MATERIALS

Indubhai Patel College of Pharmacy & Research Centre, Dharmaj

Contents..

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WHAT ARE RAW MATERIALS ? All materials that used into the manufacturing of a

finished bulk (even though it may not be present in final product e.g. Certain solvents etc.) and which are consumed by person using it are called as raw materials.

Raw materials can be either active drug or inactive substances.

eg. Hard gelatin capsules: even though it is used to fill the blend of medicine, it is not considered as package materials because it is consumed by person using medicines.

PURCHASE SPECIFICATION Definition : Written guidelines that precisely define the operational,

physical, and/or chemical characteristics, as well as the quality and quantity of a particular item to be acquired.

rawmaterial.doc Mode of purchasing : By inspection By sample By description of brand By grading

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Steps involved in purchase procedure:

1. Purchase requisition

2. Selection of supplies

3. Inviting Quotation

4. Placing the order

5. Receiving the material

6. Checking of invoice or bill

7. Recording of bills in books

8. Releasing the payment to the supplier

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Staff involved in purchasing have a particular and thorough knowledge of products and suppliers.

Raw material can be purchased from supplier named in relevant specification or directly from producer.

Specification established by manufacturer for the starting materials be discussed with suppliers.

Pharmacist or chemist, who is familiar with quality requirement of various material purchase department can be head of purchase department.

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Maintenance of storesStorage Area Specifications :-

- Sufficient Capacity- Clean, Dry and Maintained within acceptable temp. limit

- Designed and equipped reception area - Ensuring of quarantine status - Separate sampling area - Segregation for storage of rejected, recalled or returned

material - Safe and secure area for narcotics and highly active,

dangerous and risky material - First in First out rule (FIFO) - First expiring First Out (FEFO)

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Storage conditions :- - Room temp. Should be 30° C and R. H. 60% - A.C storage (25± 2 ° C & R.H. 45 – 55%) - Low temp. storage 2 – 8 ° C - Separate area for Sterile product storage in A.C - Light sensitive material in amber color container - Hermitically sealed containerLabeling of material in storage area - Designated name of product and internal code reference - Batch no. given by supplier - Status of Content - Expiry date or date beyond which retesting is necessary

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During fully computerized system used, labeling with all above information need not be necessary

Check list before storage - Integrity of package and seal - Correspondence note for the order, delivery and suppliers

labels Check list during storage -separation of rejected, recalled, quarantine, on test,

packaging materials. -quality of materialsReleased by q.c. dept. only

Selection of Vendors

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Purpose :- It is designed to evaluate suppliers and

manufacturers with an implementation scheme to assure regulatory compliance.

A system which assures that a supplier’s product is produced under controlled conditions, resulting in consistent quality conformance.

Require fully involvement and agreement of both partners.Vendor is classified by the finished dosage form

manufacturer relative to its credibility .

Determine the selling price of the API from the vendor, i.e. the cost to the finished dosage form manufacturer. This information is needed for a profitability evaluation of the finished pharmaceutical product

Begin the actual process of vendor qualification – evaluation of sample of API .

The finished dosage form manufacturer should conduct a vendor audit.

Followings are too considered… Response to the quotations invited. The price is lowest or reasonable as compared to the

competitors.

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His general behavior and attitude when the raw materials are returned by the purchaser and his reputation in the market.

SOP and Record of Vendor Certification

- Selection of Material based on ABC analysis

- Selection of Vendor for above selected material

1. Past history of supplies made by him 2. Trend of quality of material 3. Commitment to quality and delivery

dates 4. Compliance of quality parameters - Formation of vendor certification team

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- Following process components should be studied with supplier or manufactures

1. Study of suppliers mfg. process 2. Product specification and evaluation 3. Process evaluation 4. Process and specification changes & change control system

compliance - Carried out and represent Formal technical audit report of

vendor. - Based on audit finding vendor can be certified or decertified.

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Steps involved in vendor certification process Selection of customer team : to define the objectives & the potential benefits. Supplier selection . Initial supplier contacts. Process elements: 1. supplier process. 2. specification 3. process evaluation Process and specification changes. Customer specification. Supplier reporting : 1. certificate of compliance from supplier 2. feedback form to supplier. Decertification : lesser status of “ approved” or “ preferred” Adv. of certification process: - the tighter specification range.

- reducing testing by customer . - cost reduction

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SOP on receipt , storage ,sampling of materials.

A. Receipt of materials:i. Visual examination for all incoming materials Intact container, lid, seals Evidence of any physical damage to the containers Evidence of rodent or insect specification. Proper labeling in specified mannerii. Points to be checked & recorded Date of receipt Name of product, batch no., control no. assigned by

manufacturer. Quantity received against document Name of supplier Purchase order no. Excise gate pass etc.

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B. Storage of materials:i. External cleaning of container after receiving &before

storageii. Quantity verificationiii. Storage in specified area as per condition R.T./ A.C./ Cool /cold/ low humidity area.iv. Storage as per quarantine status of the material received, sampled, approved, rejected .

C. Sampling of materials:i. Sampling responsibilityii. Sampling formula usediii. Method of sampling e.g. top, middle, bottom sample is

required

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i. Material wise quantity to be sampled as per requirement of analysis.

ii. Sampling room specification: Temp. Relative humidity Air pressureiii. Specific requirement for specialized product: Sterile products Poisons or potent drugs Beta lactum products Sex hormones Steroids

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iv. Opening and closing of containers before & after sampling.

v. dress code of people doing samplingvi. Cleaning, drying, sanitization of utensils used for

sampling.vii. Identification of sampled containersviii. Sampled containers and sample collection containers

should have following details : Name of materials & manufacturer Batch no. for manufacturer Date of sampling Name & sign. Of sampler etc.

CONTROL ON RAW MATERIALS: Quality assurance should make periodic sanitation and

follow up to assure that deficiencies are corrected.Raw materials with abnormally high microbial

contamination may have to be subjected to a sterilization procedure like heat treatment, radiation or crystallization from a bactericidal solvent like alcohol.

Warehouses are the first operational area observed by the auditor to check operational compliance with cGMP & FDA regulation.

Following elements need to be considered when establishing warehouses operation:

cleanliness , floors , lighting & SOPs .19

Finished Products

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A product in the marketable pack Practically a transportable pack E.g. shipper containing salable material SOP for controlling (transfer, storage) of finished

products. Transferring of finished packs from transportable packs to

finished goods warehouse with finished goods transfer note giving batch no., quantity, date, time, etc.

Collect and analyze the samples specification against using validated test methods.

part of sample kept as retained material for it SOP. List of products should be provided to finished goods store.

Indian Pharmaceuticals LimitedFull scale calibration of weighing balance.

Sr no Calibration date

Calibrated for wt

Observed for wt.

deviation Calibrated by

Checked by

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Balance code:--------- ref SOP no: ------------Weighing m/c no: ------- Capacity Min: ---------Location no : --------- Capacity Max : -------Calibration no : ------ Month : -----------Valid up to : ---------- Frequency : ---------Usage capacity : Min. ------ Next calibration due on : -------- Max. --------

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Indian Pharmaceuticals LimitedList of standard weights

Sr no. weights Date of calibration

Validity of collection

Remarks in any

1 1.0 kg.

2 0.2 kg.

3 0.5 kg.

4 2.0 kg.

5 5.0 kg.

6 Etc.

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Indian pharmaceutical limited

Balance cleaning record.Date Type of

balanceCode no. of balance

Time of cleaning

From To

Cleaned by

Checked by

Indian pharmaceutical limitedDaily gross check of balance

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Location : Ref . SOP no:

Type of balance : Model no:

Code No. : Capacity: min :---- max: ----

Month :

Date Zero checked by

remark sign date Zero checked by

remarks

sign

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Sr.no.

Material Name

Synonymous Name/brand name

Date of receipt

Name of Manufacturer supplier

Quality receipt

Invoice No.& Date

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Indian Pharmaceuticals LimitedRaw material receiving observation sheet

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Name of Materials

Claimed grade (IP/BP/USP)

Import or mfg. LIC. no

Name and address of manufacturer

Name of packer or trader if any

Inner lining of bags

Checked against specification no.

Indian Pharmaceuticals LimitedRaw material sampling observation sheet

Ref. SOP. No.

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Sr no

BatchNo

Quantity Mfd.

Exp. No of packs sampled

Sample qty.

Container No.Sampled

Qty. Per Pack

No. of pack

Total Qty.

Sr. No. Batch no. No. Pack Damaged Type of Damaged Remarks

Observation during Sampling :Form: __________ Color: ________________Odor: __________ Foreign matter: __________Spillage if any: _______Sampled by: Name: _________ Date:_____Sample Handed: A Ref No. ________________Over to: __________

Daily stores Inward Reports of R.M

Date:

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Sr. No. Name of Items Quantity on Challan Name of Party

Temperature and Relative Humidity RecordDepartment Month

Area Prescribed Range(a)For Temp °C(b)For % RH

Room No. Ref. SOP. No.

Date Time Dry bulb temp °C

Wet bulb temp °C

% RH Initials of Officers

Remarks

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References

CGMP for Pharmaceuticals by Manohar A. PotdarGMP for Pharmaceuticals , Fifth edition , by Sidney H. Willing.Pharmaceutical Industrial Management by G.Vidyasagar. gmp-quality.com

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