{"product_id":"the-gmp-handbook-brendan-cooper-9781548370251","title":"The GMP Handbook: A Guide to Quality and Compliance","description":"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 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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Brendan Cooper\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1548370258\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781548370251\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Createspace Independent Publishing Platform\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 07\/17\/2017\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 152\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.69lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 8.00w x 0.33d","brand":"Brendan Cooper","offers":[{"title":"Paperback","offer_id":43995059421439,"sku":"9781548370251","price":25.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_e2cc45b4-a762-4bc2-9f44-1a2f0d3b1ed8.jpg?v=1683333688","url":"https:\/\/www.whiterainbookhouse.com\/products\/the-gmp-handbook-brendan-cooper-9781548370251","provider":"WR Book House","version":"1.0","type":"link"}