Guide to Good Validation Practice 3rd Edition

D&MD's Guide to Good Validation Practice, 3rd Edition is devoted to considering in greater detail the ways of complying with validation requirements at all stages of drug research, development and manufacture. The particular problems associated with the newer biopharmaceutical products are given special consideration. To complete this comprehensive guide to validation and its problems, full texts are provided of the major guidelines issued by National and International regulatory authorities, along with the relevant abstracts from the GLP, GMP, and GCP regulations. Other references include web sites for the retrieval of the text of regulations and guidelines, a list of useful publications, and of some well-known firms specializing in validation consulting.

Published: 15 August 2007

Pages: 213

PDF Format
Table of Contents
Price: $995.00 / GBP656.70