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GMP Requirements

2016. ALL RIGHTS RESERVED. GMP Requirements Gabriel Kaddu, Senior GMP Specialist Promoting the quality of Medicines Program (PQM) Pharmacopeial Convention (USP) 2016. ALL RIGHTS RESERVED. 3 GMP Procedures and standards used for WHO Prequalification (PQ) inspections Observed deficiencies during Inspections Common Manufacturers Deficiencies (PQM experience) Outline What is GMP? GMP ensures the quality of drugs, medical devices, blood, and some types of food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product.

Quality Management Requirements for QA Systems 1. Ensure products are developed correctly 2. Identify managerial responsibilities 3. Provide SOPs for production and control 4. Organize supply and use of correct starting materials 5. Define controls for all stages of manufacture and packaging. 6. Ensure finished product correctly processed and

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