A SEMINAR ON RAW MATERIALS
Transcript of A SEMINAR ON RAW MATERIALS
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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