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Pharmaceutical Quality Systems Oliver Schmidt 第1 版
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Pharmaceutical Quality Systems
Oliver Schmidt
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).
392 pages, illustrations
| メディア | 書籍 Hardcover Book (ハードカバー付きの本) |
| リリース済み | 2000年4月30日 |
| ISBN13 | 9781574911091 |
| 出版社 | Taylor & Francis Inc |
| ページ数 | 392 |
| 寸法 | 152 × 229 × 25 mm · 726 g |
| 言語 | 英語 |
| 編集者 | Schmidt, Oliver |
