Raw material

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Raw material

  1. 1. RAW MATERIALS Prepared By : Amit $hah M.Pharm Q.AIndubhai Patel College of Pharmacy & Research Centre, Dharmaj
  2. 2. Contents..2
  3. 3.  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 3 using medicines.
  4. 4. 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 grading4
  5. 5. 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 supplier5
  6. 6.  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. 6
  7. 7. Maintenance of stores Storage 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)7
  8. 8.  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 container Labeling of material in storage area - Designated name of product and internal code reference - Batch no. given by supplier - Status of Content8 - Expiry date or date beyond which retesting is necessary
  9. 9.  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 materials Released by q.c. dept. only9
  10. 10.  Selection of Vendors  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 .10
  11. 11.  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.11
  12. 12. 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 dates12 4. Compliance of quality parameters
  13. 13. - 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.13
  14. 14.  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 .14 - cost reduction
  15. 15.  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 manner ii. 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.15  Excise gate pass etc.
  16. 16. B. Storage of materials: i. External cleaning of container after receiving &before storage ii. Quantity verification iii. 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 responsibility ii. Sampling formula used iii. Method of sampling e.g. top, middle, bottom sample is required16
  17. 17. i. Material wise quantity to be sampled as per requirement of analysis. ii. Sampling room specification:  Temp.  Relative humidity  Air pressure iii. Specific requirement for specialized product:  Sterile products  Poisons or potent drugs  Beta lactum products  Sex hormones  Steroids17
  18. 18. iv. Opening and closing of containers before & after sampling. v. dress code of people doing sampling vi. Cleaning, drying, sanitization of utensils used for sampling. vii. Identification of sampled containers viii. 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.18
  19. 19. 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
  20. 20. Finished Products 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.20
  21. 21. Indian Pharmaceuticals Limited Full scale calibration of weighing balance. 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. -------- Sr no Calibration Calibrated Observed deviation Calibrated Checked date for wt for wt. by by21
  22. 22. Indian Pharmaceuticals Limited List of standard weights Sr no. weights Date of Validity of Remarks calibration collection in any 1 1.0 kg. 2 0.2 kg. 3 0.5 kg. 4 2.0 kg. 5 5.0 kg. 6 Etc. 722 8
  23. 23. Indian pharmaceutical limited Balance cleaning record. Date Type of Code Time of Cleaned Checked balance no. of cleaning by by balance From To23
  24. 24. Indian pharmaceutical limited Daily gross check of balance Location : Ref . SOP no: Type of balance : Model no: Code No. : Capacity: min :---- max: ---- Month : Date Zero remark sign date Zero remark sign checked checked s by by24
  25. 25. Indian Pharmaceuticals Limited Raw material receiving observation sheet Sr. Mat Synonymous Date of Name of Qual Invo no. eria Name/brand receipt Manufactu ity ice l name rer supplier recei No. Na pt & me Date 1. 2.25
  26. 26. Indian Pharmaceuticals Limited Raw material sampling observation sheet Ref. SOP. No. 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.26
  27. 27. Sr Batch Quantity M Exp. No of packs Sample Containerno No f sampled qty. No. d Sampled . Qty. Per No. Total Pack of Qty. pack 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:_____27 Sample Handed: A Ref No. ________________ Over to: __________
  28. 28. Daily stores Inward Reports of R.M Date: Sr. No. Name of Items Quantity on Challan Name of Party Temperature and Relative Humidity Record Department Month Area Prescribed Range (a)For Temp °C (b)For % RH Room No. Ref. SOP. No. Date Time Dry bulb Wet bulb % RH Initials of Remarks temp °C temp °C Officers28
  29. 29. References  CGMP for Pharmaceuticals by Manohar A. Potdar  GMP for Pharmaceuticals , Fifth edition , by Sidney H. Willing.  Pharmaceutical Industrial Management by G.Vidyasagar.  gmp-quality.com29
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