Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

图书简介

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 systemsAnalyzes regulatory trends and expectationsIncludes approaches and practices used in the industry to comply with regulatory requirementsDiscusses recent worldwide supply chain issuesDelivers valuable information to a worldwide audience regarding the current GMP practices in the industry

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

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition 药品良好生产规范 第7版 工业经济学

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

药品良好生产规范第7版
工业经济学