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Drugs and the Pharmaceutical Sciences
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책소개
목차
|
Preface. Contributors. About The Editor. Chapter 1: Status and Applicability of U.S. Regulations: CGMP. Chapter 2: Quality Management Systems and Risk Management. Chapter 3: Management Responsibility and Control. Chapter 4: Organization and Personnel. Chapter 5: Finished Pharmaceuticals: General Provisions. Chapter 6: Production and Process Controls. Chapter 7: Records and Reports. Chapter 8: Clinical Trial Supplies. Chapter 9: Contracting and Outsourcing. Chapter 10: Buildings and Facilities. Chapter 11: Equipment. Chapter 12: Control of Components and Drug Product Containers and Closures. Chapter 13: Holding and Distribution. Chapter 14: Returned and Salvaged Drug Products. Chapter 15: Active Pharmaceutical Ingredients. Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices. Chapter 17: Packaging and Labeling Control. Chapter 18: Laboratory Controls. Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities. Chapter 20: CGMP Enforcement Alternatives in the United States. Chapter 21: FDA Inspection Process. Chapter 22: FDA Pre-approval Inspections. Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection. Chapter 24: The Qualified Person in the Pharmaceutical Industry. Chapter 25: Data Integrity and Fundamental Responsibilities. Index |
관련 분류
품목정보
- 발행일
- 2026년 05월 25일
- 쪽수, 무게, 크기
- 402쪽 | 930g | 180*250mm
- ISBN13
- 9781041002499
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