Validated Cleaning Technologies for Pharmaceutical Manufacturing
Author | : Destin a LeBlanc |
Publisher | : CRC Press |
Total Pages | : 304 |
Release | : 2019-08-30 |
ISBN-10 | : 0367398877 |
ISBN-13 | : 9780367398873 |
Rating | : 4/5 (77 Downloads) |
Download or read book Validated Cleaning Technologies for Pharmaceutical Manufacturing written by Destin a LeBlanc and published by CRC Press. This book was released on 2019-08-30 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.