PDA TR29清洁验证考虑要点-2012(中英文)

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Tel:1(301)656-5900
Fax:1(301)986-0296
E-mail:info@pda.org
Website:www.pda.org
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, Pzer
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.
摘要:

1(301)656-5900Fax:1(301)986-0296E-mail:info@pda.orgWebsite:www.pda.orgTechnicalReportNo.29(Revised2012)PointstoConsiderforParadigmChangeinManufacturingOperationsLicensedtoJiang,Binjun/PharmaceuticalEngineering:CopyingandDistributionProhibited.PDATaskForceonTechnicalReportNo.29(Revised2012):AuthorsDe...

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