Good Manufacturing Practices for Pharmaceuticals: GMP in Practice
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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 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
Format:Paperback
Language:English
ISBN:1974006328
ISBN13:9781974006328
Release Date:July 2017
Publisher:Createspace Independent Publishing Platform
Length:152 Pages
Weight:0.69 lbs.
Dimensions:0.3" x 8.0" x 10.0"
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