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Brendan Cooper's GMP Audit Trainer: Good Manufacturing Practices Made Easy PDF

By Brendan Cooper

ISBN-10: 1548711934

ISBN-13: 9781548711931

either inner and exterior GMP audits/inspections are a key requirement of caliber administration structures throughout scientific machine, biotechnology and pharmaceutical industries. attaining a profitable audit consequence is vital to holding an efficient QMS and basic to keeping production licenses. with the intention to align platforms and strategies to make sure compliance and favorable audit results team of workers needs to comprehend the auditor concentration and methodologies. This publication summarises key components that inspections conceal alongside commonplace components of danger and situation. the subsequent chapters are included:

Introduction to reliable production
Preparation for Audits
Inspection of caliber structures
During the Inspection
Biotechnology Inspection Guide
Medical machine Inspection Guide
Drugs Inspection advisor
Computerised platforms Inspection Guide

CHAPTER 8

Computerised platforms Inspection Guide

Introduction94
Hardware 94
Validation of Hardware96
Software98
Electronic files and Signatures106
Electronic files Verification Methods117

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GMP Audit Trainer: Good Manufacturing Practices Made Easy by Brendan Cooper


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