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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 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
| Medij | Knjige Paperback Book (Knjiga z mehkimi platnicami in lepljenim hrbtom) |
| Izdano | 19. septembra 2019 |
| ISBN13 | 9780367398705 |
| Založniki | Taylor & Francis Ltd |
| Strani | 392 |
| Dimenzije | 150 × 220 × 10 mm · 453 g |
| Jezik | Angleščina |
| Urednik | Schmidt, Oliver |
