Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers / Labellers, Testers, Distributors and Importers

(November 28, 2005)

Contact Name: Drugs GMP Inspection Unit
Tel: (613) 957-1492
Fax: (613) 957-6709
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch
Inspectorate
Graham Spry Building, 2nd Floor
250 Lanark Avenue
Address Locator # 2002B
Ottawa, Ontario
K1A 0K9

November 28, 2005

05-123206-811

To: Associations

I am pleased to inform you that a new version of the document entitled "Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers / Labellers, Testers, Distributors and Importers" is now available on the Compliance and Enforcement section of the Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

This document has been reviewed as part of the Inspectorate's quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate. Please note that no changes to the requirements were made, therefore, consultation is not deemed necessary.

Inquiries about this document can be addressed to the Manager, Drugs GMP Inspection Unit by telephone at (613) 957-1492, by fax at (613) 957-6709, or by e-mail at GMP_Questions_BPF@hc-sc.gc.ca

Original signed by
Diana Dowthwaite (for)

Jean Lambert
Director General

Cover Page

OUR MANDATE:

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.