3 Review(s)

1. INTRODUCTION: CONCEPT & EVOLUTION OF QC, QA, GLP, GMP, OVERVIEW OF ICH GUIDELINES-QSEM, WITH SPECIAL EMPHASIS ON Q-SERIES GUIDELINES, 2. GOOD LABORATORY PRACTICES, 3. THE C-GMP, ITS GUIDELINES AND INTRODUCTION TO FDA (SCHEDULE M), US-FDA (INCLUSIVE OF CDER AND CBER) PHARMACEUTICAL INSPECTION CONVENTION (PIC/S), WHO & EMEA, 4. THE c-GMP GUIDELINES ACCORDING TO SCHEDULE M, USFDA (INCLUSIVE OF CDER & CBER), PHARMACEUTICAL INSPECTION CONVENTION (PIC/S), WHO & EMEA (EMA), 5. ANALYSIS OF MATERIALS, 6. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY, 7. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY-II, 8. MANUFACTURING OPERATIONS AND CONTROLS