GMP and GXP Guide for Engineers: Quality, Compliance and Inspection

By Priscilla Browne

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)

• Format: Paperback
• Language: English
• ISBN: 1974426270
• ISBN13: 9781974426270
• Release Date: August 2017
• Publisher: Createspace Independent Publishing Platform
• Length: 314 Pages
• Weight: 1.38 lbs.
• Dimensions: 0.7" x 8.0" x 10.0"