The GMP Handbook: A Guide to Quality and Compliance - Softcover

Cooper, Brendan

Softcover

ISBN 10: 1548370258 ISBN 13: 9781548370251

Publisher: CreateSpace Independent Publishing Platform, 2017

Synopsis

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters:Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality ManagementChapter 3-PersonnelChapter 4-Buildings and FacilitiesChapter 5-Process EquipmentChapter 6-Documentation and RecordsChapter 7-Materials ManagementChapter 8-Rejection and re-use of materialsChapter 9-ValidationChapter 10- Change Control Chapter 11-Complaints and recallsPage count 160. Paperback book. Large 8" x 10" format.

Edition details

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2017
• Language: English
• ISBN 10: 1548370258
• ISBN 13: 9781548370251
• Binding: Paperback
• Number of pages: 150