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Pharmaceutical Quality Systems

Pharmaceutical Quality Systems

Paperback

Medical ReferenceChemistry

ISBN10: 0367398702
ISBN13: 9780367398705
Publisher: Crc Pr Inc
Published: Sep 19 2019
Pages: 392
Weight: 1.20
Height: 0.90 Width: 6.00 Depth: 8.90
Language: English
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guidelines defining exactly how such a system has to be built. Beginning with explanations of key terms and concepts, this book covers ISO 9000 and GMP and how to combine them, and includes a matrix showing their similarities and differences. Implementation reviews illustrate how Quality (Management) Systems have been installed successfully in pharmaceutical companies. Also covered are the individual components of a Quality System; auditing, validation, and supplier qualification systems; and Hazard Analysis Critical Control Points (HACCP).

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