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Documents Guidance 2000 for Stability

DRAFT - Not for Implementation Guidance for Industry Stability Testing of Drug Substances and Drug Products DRAFT GUIDANCE This guidance document is being distributed for…

Health & Medicine Establishing A CGMP Laboratory Audit System

1. ESTABLISHING A CGMP LABORATORY AUDIT SYSTEM A Practical Guide David M. Bliesner Delphi Analytical Services, Inc. Indian Rocks Beach, Florida 2. ESTABLISHING A CGMP LABORATORY…