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...
Պահպանված է:
| Այլ հեղինակներ: | |
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| Ձևաչափ: | Գիրք |
| Լեզու: | անգլերեն |
| Հրապարակվել է: |
Boca Raton, FL
CRC Press An Imprint of Taylor & Francis Group
2019
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| Խորագրեր: | |
| Ցուցիչներ: |
Ավելացրեք ցուցիչ
Չկան պիտակներ, Եղեք առաջինը, ով նշում է այս գրառումը!
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| Ամփոփում: | "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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| Ֆիզիկական նկարագրություն: | xxii, 370 p. |
| ISBN: | 9780367398705 |