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This document provides an overview of current good manufacturing practices (CGMP) for drug manufacturing quality. It discusses the legal framework for CGMP, including what constitutes a drug. Key aspects of CGMP regulations are summarized, including requirements for facilities, equipment, components, production processes, packaging, holding, laboratories, and records. Maintaining high quality standards through adherence to CGMP helps ensure that drugs meet requirements for safety, identity, strength, qualit

Author

Gopinath Gopi

Language

EN