Pharmaceutical Manufacturing Handbook Regulations and Quality RS192.P4635 2008
Series: | |
Publisher: | Hoboken, N.J: John Wiley & Sons |
Subject: | Pharmaceutical technology--Quality control, Pharmaceutical industry--Law and legislation |
Authors: | Shayne Cox Gad |
Pages: | 1939 pages |
Binding: | Hardcover |
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.