PDA TR29清洁验证考虑要点-2012（中英文）
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Technical Report No. 29 (Revised 2012)
Points to Consider for
Cleaning Validation
Paradigm Change in
Manufacturing OperationsSM
Licensed to Jiang, Binjun/Pharmaceutical Engineering: Copying and Distribution Prohibited.
PDA Task Force on Technical Report No. 29 (Revised 2012):
Points to Consider for Cleaning Validation
Authors
Destin A. LeBlanc, Cleaning Validation Technologies
(Chair)
Gretchen Allison, Pzer
Jennifer L. Carlson, Genentech
Koshy George, Consultant
Igor Gorsky, ConcordiaValSource
Irwin S. Hirsh, Novo Nordisk AS
Jamie Osborne, Siegfried (USA), Inc.
Greg Randall, Baxter Bioscience
Pierre-Michel Riss, Eli Lilly
George Verghese, STERIS Corporation
Jenn Walsh, Bristol-Myers Squibb
Vivienne Yankah, Sano-Pasteur, Ltd.
The content and views expressed in this Technical Report are the result of a consensus achieved by the authorizing
Task Force and are not necessarily views of the organizations they represent.
Licensed to Jiang, Binjun/Pharmaceutical Engineering: Copying and Distribution Prohibited.
Points to Consider for
Cleaning Validation
Technical Report No. 29 (Revised 2012)
ISBN: 978-0-939459-48-3
© 2012 Parenteral Drug Association, Inc.
All rights reserved.
BethesdaTowers
4350EastWestHighway
Suite200
Bethesda, MD 20814USA
Tel: 1 (301)656-5900
Fax: 1 (301)986-0296
E-mail:info@pda.org
Website:www.pda.org
Licensed to Jiang, Binjun/Pharmaceutical Engineering: Copying and Distribution Prohibited.
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时间：2025-11-19
