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...
Đã lưu trong:
| Tác giả khác: | |
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| Định dạng: | Sách |
| Ngôn ngữ: | Tiếng Anh |
| Được phát hành: |
Boca Raton, FL
CRC Press An Imprint of Taylor & Francis Group
2019
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| Những chủ đề: | |
| Các nhãn: |
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| Tóm tắt: | "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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| Mô tả vật lý: | xxii, 370 p. |
| số ISBN: | 9780367398705 |