GMP Inspection Policy for Canadian Drug Establishments (POL-0011)

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(January 31, 2008)

Unit Name: Drug GMP Inspection Unit
Telephone: 613-957-1492
Fax: 613-957-6709
E-Mail: GMP_questions_BPF@hc-sc.gc.ca

Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3rd Floor
250 Lanark Avenue
Address Locator # 2003D
OTTAWA, Ontario
K1A 0K9

January 31, 2008

08-101840-593

To: ALL INTERESTED PARTIES

I am pleased to inform you that Health Canada has finalized the guidance document entitled "GMP Inspection Policy for Canadian Drug Establishments (POL-0011)", which is now available on Health Canada's Compliance and Enforcement website under "What's New"

This document has been reviewed as part of the Inspectorate's quality management process and has been amended to increase efficiencies in the scheduling of inspections and delivery of the Drug GMP Inspection Program.

This version re-iterates the requirement for new establishments when applying for an establishment licence to be ready for an inspection when submitting their application, as the Inspectorate expects that all proper information and systems are in place at the time of inspection. The Inspectorate is committed to perform an initial inspection within 3 months following the date of receipt of the request.

If establishments are not prepared for an initial inspection when contacted by the Inspectorate, their EL application will be withdrawn. The company will have to resubmit an EL application with all supporting information.

For all inspections, once the date of inspection has been set and the establishment informed, the inspection should take place on the date scheduled by the Inspectorate. Changes to dates of scheduled inspections will only be done at the discretion of the inspectorate and upon receipt of sufficient justification from the establishment.

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 at GMP_questions_BPF@hc-sc.gc.ca .

Yours truly,

Original signed by

Director General
Diana Dowthwaite

Cover Page

OUR MANDATE:

To take an integrated approach to managing the health-related risks and benefits of health products and food by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food, and by promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

Health Products and Food Branch Inspectorate
GMP Inspection Policy for Canadian Drug Establishments
POLICY-0011

Supersedes:
January 1, 2004

Date Issued
January 31^st, 2008

Date of implementation
January 31^st, 2008

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