000			01854nam a22002417a 4500
005			20221022090424.0
008			221021b ||||| |||| 00| 0 eng d
020			_a9781974006328
040			_cAL
041			_aeng
082			_223 _a615.19 _bCOOG
100			_aB N Cooper _960099
245			_aGood manufacturing practices for pharmaceuticals: _bGMP in practice
260			_aUSA _bCreatespace Independent Publications _c2017
300			_a150p. _bPB _c25x20cm.
365			_2Biotechnology _a4986 _b2120.00 _c₹ _d2650.00 _e20% _f18-10-2022
520			_aCGMP, 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
650			_aQuality Management _960095
650			_aBuildings and Facilities _960096
650			_aMaterials Management _960097
700			_aCOOPER (B N) _960098
942			_2ddc _cBK
999			_c224900 _d224900