Validated Cleaning Technologies for Pharmaceutical Manufacturing

1st Edition

Destin A. LeBlanc

CRC Press
Published February 28, 2000
Reference - 304 Pages
ISBN 9781574911169 - CAT# PH1663

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Summary

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.

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