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Description
Pharmaceutical Regulatory Inspections - Guide to Quality and Compliance - 2nd editionEdited by Madhu Saghee, Tim Sandle and Gary Bird This book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings. The book compares inspections by the major regulatory agencies, the FDA, EU and Japan, as well as international inspections. This is a unique book in which agency inspectors and seasoned industry

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