Letter - Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule C Drugs (GUI-0026)

Contact Information

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

November 19, 2010

10-122465-532

To: All Interested Parties

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule C Drugs (GUI-0026)", which is now available on Health Canada's Compliance and Enforcement website under "What's New".

Due to unanticipated circumstances which have caused delays in the posting of information on the website of Health Canada, a notification was posted online on August 7^th, 2009 informing stakeholders that GUI-0026 was available upon request for comments for a period of 90 days. Thus, comments received from stakeholders and interested parties were reviewed and considered for the final version of this document. It should be noted that the commented version of GUI-0026 will not be posted on the website of Health Canada but can be obtained upon request.

Overall, the present edition of this document includes new interpretations added under the following sections: Personnel, Raw Material Testing, Quality Control Department, Finished Product Testing, Stability, and Sterile Products.

Inquiries about this guidance document can be submitted in writing by mail to the Manager, Drug Good Manufacturing Practices (GMP) Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. 2007B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613-957-6709, or by e-mail at Drug GMP Unit.

Yours truly,

Original signed by

Diana Dowthwaite
Director General