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…
1. TAM13295 S.L.C. 113TH CONGRESS 1ST SESSION S. ll To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security,…
Slide 1 Quality control of raw materials and in-process control (Cont.) Slide 2 In general, raw materials may be classified into two groups (1) active or therapeutic…
Slide 1 1 GMP Inspection Process Introduction Slide 2 2 Programme Objectives 1.Familiarise with GMP inspection 2.How to perform an inspection 3.Developing an action plan…
Introduction Development of oral pharmaceutical drug products presents many technical and regulatory challenges. Speci¢cally, these include proper characterization of active…