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Points to Consider for Cleaning Validation

BethesdaTowers4350 EastWestHighwaySuite200 Bethesda, MD20814 USATel:1 (301)656-5900 Fax:1 Report No. 29 (Revised 2012) Points to Consider for Cleaning ValidationParadigm Change in Manufacturing Task Force on Technical Report No. 29 (Revised 2012): Points to Consider for Cleaning ValidationAuthorsDestin A. LeBlanc, Cleaning Validation Technologies (Chair)Gretchen Allison, PfizerJennifer L. Carlson, GenentechKoshy George, ConsultantIgor Gorsky, ConcordiaValSourceIrwin S. Hirsh, Novo Nordisk ASJamie Osborne, Siegfried (USA), Randall, Baxter BiosciencePierre-Michel Riss, Eli LillyGeorge Verghese, STERIS CorporationJenn Walsh, Bristol-Myers SquibbVivienne Yankah, Sanofi-Pasteur, 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 to Consider for Cleaning Validation Technical Report No.

ments and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Phar- ... 9.1 Cleaning Validation Master Plans ..... 69 9.1.1 Elements of a Comprehensive Plan.... 70. 9.1.2 Harmonization of Site Cleaning ...

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Technical Report No. 65

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Validation of Dry Heat Processes Used for Depyrogenation ...

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apic.cefic.org

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www.pharmig.org.uk

Cleaning validation Cleaning validation - methodology applied to give the assurance that a cleaning process has removed residues and contaminants from a piece of equipment or machinery. Residues: •Microorganisms •Active pharmaceutical ingredients •Other process chemicals, such as buffers •Cleaning agents themselves (detergents)

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CLEANING VALIDATION WITH RISK ASSESSMENT

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Walsh, A. “Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II,” Pharmaceutical Engineering, September/October 2011, Volume 31, Number 5, pp. 44 -49

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CLEANING(VALIDATION:( BASIC(PRINCIPLES( - DCVMN

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© Pharmaceutical Consultancy Services, All rights reserved. CLEANING(VALIDATION:(BASIC(PRINCIPLES

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