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 chaptersChapter 1Overview of Good Manufacturing Practices Chapter 2Quality ManagementChapter 3PersonnelChapter 4Buildings and FacilitiesChapter 5Process EquipmentChapter 6Documentation and RecordsChapter 7Materials ManagementChapter 8Rejection and reuse of materialsChapter 9ValidationChapter 10 Change Control Chapter 11Complaints and recallsPage count 160. Paperback book. Large 8" x 10" format.

Binding: Paperback;152 pages; Publisher: Amazon Digital Services LLC - KDP; Classification: N/A; Weight: 437.06 g; Dimensions: N/A

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