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Bhawini

Quality assurance

Chandrashekhar3
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Bhawini

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  1. INTRODUCTION Maintenance of Equipment • The installation of equipment should be such that the risk of contamination or error is minimised. • Fixed pipework should be labelled clearly showing the contents and direction of flow. • Production and control operations should utilise balances and other measuring equipment of appropriate range and precision. • The equipment should be washed, cleansed, and dried to prevent the risk of contamination. • Closed or contained equipment should be preferably used and while using open equipment or when equipment is opened , additional precautionary steps should be taken to reduce the contamination risk.

  2. • A cleansing procedure should include the following details to enable the operators to clean each type of equipment in an effective and reproducible manner: 1. Assignment of responsibility for cleaning of equipment, 2. Detailed cleaning and sanitising schedules, 3. Detailed methods and materials, including dilution of cleaning agents used for cleaning the equipment, 4. Guidelines for disassembling and reassembling each part of equipment to ensure proper cleaning, 5. Guidelines for removing or destroying previous batch identification, 6. Guidelines for protecting clean equipment from contamination before their use, 7. Inspection of equipment for cleanliness just before use.

  3. Purchase Specification Purchase Specification 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. Mode of purchasing • By inspection • By sample • By description of brand • By grading

  4. Steps of purchasing Steps of purchasing 1. Purchase requisition application, 2. Selection of supplies, 3. Inviting quotation, 4. Placing the order, 5. Receiving the material, 6. Checking the invoice or bill, 7. Recording of bills in books , and 8. Releasing the payment to the supplier.

  5. • Purchasing staff should have a specific and intense knowledge of products and suppliers. • Purchasing of raw material should be done from supplier named in relevant specifications or directly from producer. • Pharmacist or chemist having knowledge and experience of quality requirement of various material purchase department can be the head of purchase department. REFERANCE:- Prof . (Dr.) R. Sundhararajan Dr. M.V. Kumudhavalli Dr. Minal T. Harde

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