Overview

"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)"

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9781974426270

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