{"product_id":"gmp-and-gxp-guide-for-priscilla-browne-9781974426270","title":"GMP and GXP Guide for Engineers: Quality, Compliance and Inspection","description":"The GMP and GXP Guide for Engineers brings together regulatory guidance and industry norms into a paperback resource for Engineers and professionals working in Life Sciences (Medical devices, Pharamceutical and Biotechnology). It is a powerful resource for those looking to refresh knowledge or those who wish to have a practical resource at their fingertips. The title is divided into five comprehensive chapters.Chapter 1-Good Manufacturing Practices (GMP): This chapter reviews the body of guidance and regulations on GMP published by the FDA, PICs, EU GMP and WHO. It will provide the reader with a broad understanding of what is required to meet GMP in a manufacturing setting.Chapter 2-Data Integrity, reviews the increasingly critical area of Data and ensuring data reliability and integrity in a CGMP setting.Chapter 3-Test Method Validation, takes the reader through the fundamentals of TMV. Chapter 4-Cleaning and GMP, provides an overview of a process approach to cleaning along with an explanation of key concepts. In conclusion, Chapter 5-Audit and Inspection Guide, examines auditor approaches and key focus areas on what is expected for onsite inspection. (Large Paperback 8\" X 10\", 310 pages)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Priscilla Browne\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1974426270\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781974426270\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 08\/09\/2017\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 314\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.38lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 8.00w x 0.66d","brand":"Priscilla Browne","offers":[{"title":"Paperback","offer_id":43984010674431,"sku":"9781974426270","price":19.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_a191e5e2-eaae-436a-a87f-e0d4d84311e4.jpg?v=1683270003","url":"https:\/\/www.whiterainbookhouse.com\/products\/gmp-and-gxp-guide-for-priscilla-browne-9781974426270","provider":"WR Book House","version":"1.0","type":"link"}