Pharmaceutical Quality Systems

Book Overview

When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guidelines defining exactly how such a system has to be built. Beginning with explanations of key terms and concepts, this book 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).

• Format: Paperback
• Language: English
• ISBN: 0367398702
• ISBN13: 9780367398705
• Release Date: September 2019
• Publisher: CRC Press
• Length: 392 Pages
• Weight: 1.20 lbs.
• Dimensions: 0.9" x 6.0" x 8.9"