01854nam a22002417a 4500 20221022090424.0 221021b ||||| |||| 00| 0 eng d 9781974006328 AL eng 23 615.19 COOG B N Cooper 60099 Good manufacturing practices for pharmaceuticals: GMP in practice USA Createspace Independent Publications 2017 150p. PB 25x20cm. Biotechnology 4986 2120.00 ₹ 2650.00 20% 18-10-2022 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 recalls Quality Management 60095 Buildings and Facilities 60096 Materials Management 60097 COOPER (B N) 60098 ddc BK 224900 224900 0 0 ddc 0 0 BT AL AL 2022-10-20 Biblios Book Point, Surathkal, Mangalore-575014 2120.00 1 615.19 COOG 076143 2026-01-09 16:13:31 2026-01-05 2650.00 2022-10-21 BK