Validated Cleaning Technologies for Pharmaceutical Manufacturing Contributor(s): LeBlanc, Destin a. (Author) |
|
ISBN: 0367398877 ISBN-13: 9780367398873 Publisher: CRC Press OUR PRICE: $78.84 Product Type: Paperback - Other Formats Published: September 2019 |
Additional Information |
BISAC Categories: - Medical | Pharmacy - Medical | Pharmacology - Science | Chemistry - General |
Dewey: 615.19 |
Physical Information: 0.7" H x 6" W x 9" (1.60 lbs) 304 pages |
Descriptions, Reviews, Etc. |
Publisher Description: 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. |