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).
Produkteigenschaften
- Artikelnummer: 9781574911091
- Medium: Buch
- ISBN: 978-1-57491-109-1
- Verlag: CRC Press
- Erscheinungstermin: 30.04.2000
- Sprache(n): Englisch
- Auflage: 1. Auflage 2000
- Produktform: Gebunden, HC gerader Rücken kaschiert
- Gewicht: 720 g
- Seiten: 392
- Format (B x H x T): 157 x 235 x 26 mm
- Ausgabetyp: Kein, Unbekannt
