Health Products and Food BranchInspectorateGraham Spry Building, 3
rd
Floor 250 Lanark AvenueAddress Locator # 2003DOTTAWA, OntarioK1A 0K9January 4, 200807-128997-672TO: ALL INTERESTED PARTIESI am pleased to inform you that Health Canada has finalized the guidance document entitled“Cleaning Validation Guidelines (GUIDE-0028)”, which is now available on Health Canada’sCompliance and Enforcement website at:http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.htmlThis document has been reviewed as part of the Inspectorate’s quality management process andhas been amended to further clarify issues brought to the attention of the Inspectorate. Please note thatno changes to the requirements were made, therefore, consultation is not deemed necessary.Inquiries about this guidance document can be submitted in writing by mail to the Manager,Drug GMP Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. #2002B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613 957-6709, or by e-mail atGMP_questions_BPF@hc-sc.gc.ca.
Original signed by
Diana DowthwaiteDirector General
Health CanadaHealth Products and Food Branch
OUR MANDATE:
To take an integrated approach to managing the health-related risks and benefits of health products and food by minimizing healthrisk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food, and promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informeddecisions about their health.
Health Products and Food Branch Inspectorate
Guidance DocumentCleaning Validation GuidelinesGUIDE-0028
Supersedes:May 1, 2000Date issued:January 1, 2008Date of implementationJanuary 1, 2008Ce document est aussi disponible en français.
Health Canada / Health Product and Food Branch InspectorateCleaning Validation Guidelines (GUIDE-0028) / December 1, 2007 Page 2
TABLE OF CONTENTS
1.0 Scope.........................................................................Page 32.0 Introduction....................................................................Page 33.0 Principles......................................................................Page 34.0 Validation of Cleaning Processes...................................................Page 45.0 Equipment and Personnel.........................................................Page 56.0 Microbiological Considerations....................................................Page 57.0 Documentation.................................................................Page 68.0 Analytical Methods..............................................................Page 79.0 Sampling, Rinsing, Rinse Samples and Detergents.....................................Page 710.0 Establishment of Limits.........................................................Page 911.0 Change Control/revalidation......................................................Page 912.0 References...................................................................Page10
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