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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. These were a response to concerns about substandard drug manufacturing practices occurring in the past.

Complaint handling . 11 ©2016. ALL RIGHTS RESERVED. 12 . Premises and Equipment . Design and maintenance of facilities . Calibration and testing of equipment . ... ups. Contamination. Cross contamination ©2016. ALL RIGHTS RESERVED. 14 Production Manufacturing Documentation . Contamination – microbial . Contamination

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