Good Manufacturing Practices for Pharmaceuticals (Drugs and the Pharmaceutical Sciences) （8TH）

個数：

予約

Good Manufacturing Practices for Pharmaceuticals (Drugs and the Pharmaceutical Sciences) （8TH）

Bunn, Graham P. (EDT)

ウェブストア価格 ¥55,968（本体¥50,880）
CRC Press（2026/05発売）
外貨定価 US$ 250.00
ポイント 508pt

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製本 Hardcover:ハードカバー版／ページ数 384 p.
言語 ENG
商品コード 9781041002499

Full Description

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

Key Features

Presents insight into the world of pharmaceutical quality systems.
Analyzes regulatory trends and expectations.
Includes approaches and practices used in the industry to comply with regulatory requirements.
Discusses recent worldwide supply chain issues.
Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry.

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