1787573
9781574911169
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.Destin A. LeBlanc is the author of 'Validated Cleaning Technologies for Pharmaceutical Manufacturing', published 2000 under ISBN 9781574911169 and ISBN 1574911163.
[read more]