01764nam a22002177a 450000500170000000800410001702000180005804000070007604100080008308200210009110000150011224500710012726000520019830000240025036500640027452011140033865000230145265000290147565000250150470000170152920221022090424.0221021b           ||||| |||| 00| 0 eng d  a9781974006328  cAL  aeng  223a615.19bCOOG  aB N Cooper  aGood manufacturing practices for pharmaceuticals:bGMP in practice  aUSAbCreatespace Independent Publicationsc2017  a150p.bPBc25x20cm.  2Biotechnologya4986b2120.00c₹d2650.00e20%f18-10-2022  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  aQuality Management  aBuildings and Facilities  aMaterials Management  aCOOPER (B N)