医薬品適正製造基準：GMP（第７版）<br>Good Manufacturing Practices for Pharmaceuticals, Seventh Edition (Drugs and the Pharmaceutical Sciences) （7TH）

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医薬品適正製造基準：GMP（第７版）
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition (Drugs and the Pharmaceutical Sciences) （7TH）

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  • 製本 Hardcover:ハードカバー版／ページ数 371 p.
  • 言語 ENG
  • 商品コード 9781498732062
  • DDC分類 338.476151

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

Contents

Preface

Editor

Contributors

1. Status and Applicability of U.S. Regulations: CGMP

Graham P. Bunn

2. Quality Management Systems and Risk Management

Joseph C. Near

3. Management Responsibility and Control

John E. Snyder

4. Organization and Personnel

Graham P. Bunn and Joanna B. Gallant

5. Finished Pharmaceuticals: General Provisions

Graham P. Bunn

6. Production and Process Controls

Jocelyn A. Zephrani

7. Records and Reports

Graham P. Bunn

8. Clinical Trial Supplies

David Stephon

9. Contracting and Outsourcing

Joseph C. Near

10. Buildings and Facilities

Robert Del Ciello

11. Equipment

Robert Del Ciello and Joseph T. Busfield

12. Control of Components and Drug Product Containers and Closures

Graham P. Bunn

13. Holding and Distribution

Andrew Acker

14. Returned and Salvaged Drug Products

Graham P. Bunn

15. Active Pharmaceutical Ingredients

Joseph C. Near

16. Pharmaceutical Excipient Good Manufacturing Practices

Irwin Silverstein

17. Packaging and Labeling Control

Graham P. Bunn

18. Laboratory Controls

Alex M. Hoinowski

19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy

Dawn McIver

20. CGMP Enforcement Alternatives in the United States

Daniel G. Jarcho and Cathy L. Burgess

21. FDA Inspection Process

Cathy L. Burgess and Daniel G. Jarcho

22. FDA Pre-approval Inspections

Cathy L. Burgess, Justin Mann, and Seth Olson

23. Worldwide Good Manufacturing Practices

Dominic Parry

24. Data Integrity and Fundamental Responsibilities

Randy Hightower and Michele Pruett

Index