GMP and GXP Guide for Engineers: Quality, Compliance and Inspection - Couverture souple

Browne, Priscilla

 
9781974426270: GMP and GXP Guide for Engineers: Quality, Compliance and Inspection
Couverture souple
ISBN 10 : 1974426270 ISBN 13 : 9781974426270
Editeur : CreateSpace Independent Publishing Platform, 2017

Synopsis

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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Éditeur
CreateSpace Independent Publishing Platform
Date d'édition
2017
Langue
anglais
ISBN 10 
1974426270
ISBN 13 
9781974426270
Reliure
Broché
Nombre de pages
312
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
https://www.amazon.fr/hz/contact-us

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