The following are links to useful articles and information related to GMP compliance and Drug product manufacturing:
Useful Links
Article On CAPA and Risk in Compliance - By G. Amer; Pharmaceutical Engineering, May/June 2008
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FDA warning letters
Article on Change Control and the Validation Life Cycle - By G. Amer; JVT May 2005
Article on Critical Documentation Requirements For Successful Validation - By G. Amer; JVT Winter 2008
List of Acronyms used in the Healthcare Industry - Compiled by PremierC
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Additional articles on Validation by G. Amer
Preparation of a Validation Master Plan
Process Validation: An Overview
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Article on GMP Monitoring- What, Why, Where, and How - By G. Amer; JVT Winter 2009
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