Thursday, 16.04.2012

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL for API Inspection

New FOOD and DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL for Active Pharmaceutical Ingredient (API) process inspection

Summary:

This revised program defines a systems approach; incorporates Q7a guidance; updates the regulatory/administrative strategy at part V; updates contacts and references; changes profile sample collection instructions; defers to 7356.002m for biotech APIs

http://www.fda.gov/cder/dmpq/7356-002f-CDER.pdf

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