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...
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| Format: | Livre |
| Langue: | anglais |
| Publié: |
Boca Raton, FL
CRC Press An Imprint of Taylor & Francis Group
2019
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| 020 | |a 9780367398705 | ||
| 082 | |a 615.190218 |b PHA | ||
| 245 | |a Pharmaceutical Quality Systems | ||
| 260 | |a Boca Raton, FL |b CRC Press An Imprint of Taylor & Francis Group |c 2019 | ||
| 300 | |a xxii, 370 p. | ||
| 520 | |a "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)." | ||
| 650 | |a Pharmaceutical Industry - Standards |9 7522 | ||
| 650 | |a Pharmaceutical Chemistry |9 7522 | ||
| 700 | |a Schmidt, Oliver |9 8485 | ||