Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. The new guides will be posted when the documents are finalized.

Unanticipated circumstances have caused delays in the posting of some information online. Notification of documents available "for comment" will be posted online and the actual documents will be released upon request.

The following documents have been reviewed as part of the Inspectorate's quality management process and have been amended to further clarify issues brought to the attention of the Inspectorate. Highlights of additional changes specific to each document are listed below each document.

Comments are Requested on the Following Draft Documents:

• Alternate Sample Retention Site (GUI-0014)
  • The document has been reviewed and amended to provide a clearer understanding of the application of regulatory requirements to facilitate compliance by the regulated industry, and to enhance consistency in the application of the regulatory requirements.
  • The major changes include revisions to the scope section, the appendix section and removal of the list of non-prescription drugs.
    
    
• Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069)
  • A definitions section has been added.
  • Additional requirements have been added to the Warehousing and Storage, Product Transportation and Products in Transit, Receiving and Documentation sections.
  • All sections contain re-wording to improve clarity.
  • Examples have been added in the Interpretation sections for context.

Please see below to comment on these 2 consultations.

How to Get Involved

Both consultations below are open for comment for 90 days, starting August 7, 2009 until November 5, 2009.

To request documents: Interested stakeholders who wish to provide comments may contact the Drug Good Manufacturing Practices Inspection Unit to request an electronic copy or alternate format of any of the documents.
Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.

Comments are Requested on the Following Draft Documents:

• Alternate Sample Retention Site (GUI-0014)
• Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069)

Comments received from stakeholders and interested parties will be reviewed after the 90 day comment period.

Interested parties are encouraged to provide comments and suggestions by November 5, 2009 on any of the above documents.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.
If you have any questions, contact us at Drug Good Manufacturing Practices Inspection Unit.

Yours truly

Original signed by

Diana Dowthwaite
Director General