Procurement and storage of Materials in Pharmaceutical Industries including Vendor Selection.

1. Procurement and storage of Materials in Pharmaceutical Industries including Vendor Selection. Sankar Gupta ADC(I), CDSCOEZ, KOLKATA

2. What to procure ? How to procure ? How to store ? What is Vendor Selection ? S Gupta 2

3. What to procure Materials : Starting materials Packaging materials Intermediate and Bulk products Finished products Reference Standards Reference Strains Reagents and Culture media Rejected and Recovered materials Recalled products Returned goods Waste materials Miscellaneous Insecticides Disinfectants Fumigating agents Sanitizing materials S Gupta 3

4. How to procure Prerequisites : Specification [ approved ] Approved Vendor(s) Standard Operating Procedures S Gupta 4

5. How to procure - Specification Specifications Pharmacopoeial parameters In-house parameters BIS parameters Nature of packing including packaging size, container, label etc. Approval of specification S Gupta 5

6. How to procure - Specification Revised Schedule M states : 1 Specification for Raw materials and Packaging materials They shall include - a) the designated name and internal code reference; b) reference, if any, to a pharmacopoeial monograph; c) qualitative and quantitative requirements with acceptance limits; d) name and address of manufacturer or supplier and original manufacturer of the material; e) specimen of printed material; f) directions for sampling and testing or reference to procedures; g) storage conditions; and h) maximum period of storage before re-testing. S Gupta 6

7. How to procure - Specification 2. For Product Containers and Closures- A. All containers and closures intended for use shall comply with the pharmacopoeial requirements. Suitable validated test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, wherever indicated, shall be strictly followed to ensure that these are not reactive, additive, adsorptive, or leach to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. B. Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, they should be rinsed with de-ionised water or distilled water, as the case may be. S Gupta 7

8. How to procure - Specification 3. For in-process and bulk products.- Specifications for in-process material, intermediate and bulk products shall be available. The specifications should be authenticated. S Gupta 8

9. How to procure - Specification 4. For Finished Products.- Appropriate specifications for finished products shall include : a) the designated name of the product and the code reference; b) the formula or a reference to the formula and the pharmacopoeial reference; c) directions for sampling and testing or a reference to procedures; d) a description of the dosage form and package details; e) the qualitative and quantitative requirements, with the acceptance limits for release; f) the storage conditions and precautions; where applicable, and g) the shelf-life. S Gupta 9

10. How to procure - Specification 5. For preparation of containers and closures.- The requirements mentioned in the Schedule do not include requirements of machinery, equipment and premises required for preparation of containers and closures for different dosage forms and categories of drugs. The suitability and adequacy of the machinery, equipment and premises shall be examined taking into consideration the requirements of each licensee in this respect. S Gupta 10

11. How to procure - Approved Vendor Vendor approval : Initial enquiry Vendor audit Sample testing/approval Commercial negotiation with details of specification Provisional approval of vendor Final approval of vendor vendor is never permanently approved * S Gupta 11

12. How to procure - S.O.P. S.O.P.s required for operations like: Placement of order to approved vendor Checking of incoming material label verification damage and contamination comparison with order document/invoice Dedusting / cleaning of material containers Requisition for sampling by Q.C. personnel Order form Sampling requisition form Quarantining of material immediately after receipt / processing with appropriate label Segregation of material after initial rejection with appropriate label S Gupta 12

13. How to procure - S.O.P. Revised Schedule M emphasised on following S.O.P.s and records 1. Receipt of Materials; 2. There shall be written Standard Operating Procedures and records for the receipt of each delivery of raw, primary and printed packaging material. S Gupta 13

14. How to procure - S.O.P. 3 The records of the receipts shall include; a) the name of the material on the delivery note and the number of the containers; b) the date of receipt; c) the manufacturer’s and / or supplier’s name; d) the manufacturer’s batch or reference number; e) the total quantity, and number of containers, quantity in each container received; f) the control reference number assigned after receipt; g) any other relevant comment or information. S Gupta 14

15. How to procure - S.O.P. 4. There shall be written standard operating procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate. S Gupta 15

16. Adequate and separate area for orderly warehousing of Starting materials Packaging materials Intermediates Bulk products Finished products Products in quarantine Released products Rejected products Returned / Recalled goods How to Store. S Gupta 16

17. How to Store. Such storage area Can be A/C Store [with temp. humidity control] Non-A/C Store Controlled Substance Store [such as hazardous, poisonous and explosive materials - NDPS - inflammable] S Gupta 17

18. How to Store. To ensure : Good and appropriate storage condition Clean, dry and maintained within acceptable temp. limits Special Storage Condition with temp.and humidity requirement [with necessary temp. and humidity record] Appropriate house-keeping Control arrangement for rodents / pests / vermin with necessary record maintenance Proper arrangement for racks, bins, platform Receiving and Despatch bays are covered S Gupta 18

19. How to Store. Sampling and dispensing area Sampling booth Dispensing booth Separate dispensing area for Beta lactum, Sex hormones and Cyto-toxic substances Sampling and dispensing of sterile materials under aseptic conditions (grade A) S Gupta 19

20. Recommendation of Revised Schedule M under the heading Raw materials 1. The licensee shall keep an inventory of all raw-materials to be used at any stage of manufacture of drugs and maintain records as per Schedule U. S Gupta 20

21. Raw materials 2. All incoming materials shall be quarantined immediately after receipt or processing. All materials shall be stored under appropriate conditions and in an orderly fashion to permit batch segregation and stock rotation by a ‘first in / first expiry’ - ‘first-out’ principle. All incoming materials shall be checked to ensure that the consignment corresponds to the order placed. S Gupta 21

22. Raw materials 3. All incoming materials shall be purchased from approved sources under valid purchase vouchers. Wherever possible, raw materials should be purchased directly from the producers. 4. Authorised staff appointed by the licensee in this behalf, which may include personnel from the quality control department, shall examine each consignment on receipt and shall check each container for integrity of package and seal. Damaged containers shall be identified, recorded and segregated. S Gupta 22

23. Raw materials 5. If a single delivery of material is made up of different batches, each batch shall be considered as a separate batch for sampling, testing and release. S Gupta 23

24. Raw materials 6. Raw materials in the storage area shall be appropriately labeled. Labels shall be clearly marked with the following information : a) designated name of the product and the internal code reference, where applicable, and analytical reference number; b) manufacturer’s name, address and batch number; c) the status of the contents (e.g. quarantine, under test, released / approved, rejected); d) the manufacturing date, expiry date and re-test date. S Gupta 24

25. Raw materials 7. There shall be adequate separate areas for materials “under test”, “approved”, and “rejected” with arrangements and equipment to allow dry, clean and orderly placement of stored materials and products, wherever necessary, under controlled temperature and humidity. S Gupta 25

26. Raw materials 8. Containers from which samples have been drawn shall be identified. S Gupta 26

27. Raw materials 9. Only raw materials which have been released by the Quality Control Department and which are within their shelf-life shall be used. It shall be ensured that shelf-life of formulation product shall not exceed that of active raw materials used. S Gupta 27

28. Raw materials 10. It shall be ensured that all the containers of raw materials are placed on the raised platforms / racks and not placed directly on the floor. S Gupta 28

29. Vendor Selection Vendor Can be Material supplier Service supplier Selection procedure not required for Intermediates Bulk products Finished products S Gupta 29

30. Vendor Selection Selection procedure required for suppliers of Starting materials Packaging materials Printed materials Ref. Standard Ref. Strains Reagents and Culture media S Gupta 30

31. Vendor Selection Selection procedure also required for service providers like Laboratory service Maintenance / Validation /Calibration service Environment Control / Pest Control service Medical examination service S Gupta 31

32. Inventory Control and logistics No accumulation No Shortage Proper procurement Appropriate Storage and issuance Traceable documentation. S Gupta 32

33. THANKS