Good Manufacturing Practices (GMP) for Medical Gases (GUIDE-0031)

(December 29^nd, 2006)

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

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Cover Letter

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

December 29, 2006

06-123804-747

To: Associations

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031)", which is now available on Health Canada's Compliance and Enforcement website at:

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

The updated guideline, which replaces the previous 2001 version, states generally applicable principles and practices that are acceptable to the Health Products and Food Branch (HPFB) Inspectorate and should facilitate compliance of fabricators, packagers/labellers, wholesalers, distributors, importers and home care providers of medical gases with Division 2, Part C of the Food and Drug Regulations on GMPs.

This guideline was revised to reflect the current regulatory environment and to clarify certain aspects that have relevance to the manufacture of medical gases.

Many interpretations have been further clarified and several new requirements have been added to such sections as Raw Material Testing, Quality Control Department, Finished Product Testing, and Records. This revision also includes the addition of a "Quality Management" section, an updated glossary, the addition of Appendices A and A1 ("Internationally Harmonized Requirements for Batch Certification" and "Designated Regulatory Authorities"), and an updated list of references.

A draft version of the document was posted on the Health Canada website for a 60 day comment period in June 2006. Comments received from stakeholders and interested parties were reviewed and those that were accepted have been incorporated in this new version.

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 .

Original signed by

Diana Dowthwaite
Director General

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 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

Good Manufacturing Practices (GMP)
for Medical Gases

(GUIDE-0031)

Supersedes:
July 1^st, 2000

Date issued:
December 2006

Date of implementation:
December 2006

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