Pharmaceutical Quality Systems
"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...
保存先:
| その他の著者: | |
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| フォーマット: | 図書 |
| 言語: | 英語 |
| 出版事項: |
Boca Raton, FL
CRC Press An Imprint of Taylor & Francis Group
2019
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| 主題: | |
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| 要約: | "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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| 物理的記述: | xxii, 370 p. |
| ISBN: | 9780367398705 |