Overview
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: Routledge
- | Publication Date: Sep 19, 2019
- | Number of Pages: 392 pages
- | Language: English
- | Binding: Paperback
- | ISBN-10: 0367398702
- | ISBN-13: 9780367398705
