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).
| Author: Oliver Schmidt |
| Publisher: CRC Press |
| Publication Date: Apr 30, 2000 |
| Number of Pages: 392 pages |
| Binding: Hardback or Cased Book |
| ISBN-10: 1574911090 |
| ISBN-13: 9781574911091 |
