Pharmaceutical Quality Systems
MIA KARTS BOOKS
Pharmaceutical Quality Systems
Book Details
- Author
- Oliver Schmidt
- Publisher
- CRC Press
- Format
- Paperback
- Language
- English
- Category
- General & Reference
- Condition
- New
- ISBN-13
- 9780367398705
- ISBN-10
- 0367398702
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ISBN: 0367398702
Author: Schmidt, Oliver
Condition: New
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a practical guide to building a quality system. Beginning with explanations of key terms and concepts, it 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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Pharmaceutical Quality Systems
