Letter - Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2 (GUI-0001)

Contact Information:

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

March 4, 2011

11-100914-373

To: All Interested Parties

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2 (GUI-0001)", which is now available on Health Canada's Compliance and Enforcement website under "What's New".

Overall, version 2 of the present edition of this document includes recent regulatory amendments to Part C, Division 2 (GMP) of the Food and Drug Regulations, clarification of existing requirements, and the new interpretations pertaining to crimping requirements (C.02.029 Sterile Products, Interpretation 80.11).

Inquiries about this document can be submitted either by mail to the Manager, Drug GMP Unit, Health Products and Food Branch Inspectorate, Graham Spry Building, A.L. #2007B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613 957-6709, or by email at Good Manufacturing Practices Unit.

Yours truly,

Original signed by

Diana Dowthwaite
Director General