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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
| Author | Kishor S.Jain, Pravin J. Patil, Jyoti N. Kadam |
| Publisher | Nirali Prakashan |
| Language | English |
| Binding Type | Paper Back |
| Main Category | Medical |
| ISBN13 | 9789361098284 |
| SKU | BK 0206114 |
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