ARCHIVED - Consultation on Good Manufacturing Practices - Program Review

 

The online consultation is now closed. The content found on this page is a snapshot of the online consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. A summary report is available.

Health Canada is currently conducting a review of its Good Manufacturing Practices (GMP) inspection program for drug establishments in an effort to make the program more risk-based. A number of factors highlighted the need for a review at this time, including the growing complexity of health products now available on the Canadian market and international trends related to GMP inspections. The review involves a detailed evaluation of all aspects of the GMP program including such things as inspection scheduling and the conduct of inspections.

A number of changes are being explored and, as an industry stakeholder, Health Canada would appreciate your input on several key concepts that are under consideration.  Specifically, we are looking for input on (i) how we assess the risk posed by an establishment's activities; (ii) appropriate inspection cycles for different levels of risk; and (iii) tools that can be developed to make the inspection program more risk focused.

There are two components of the GMP Review Consultation:

If you would like to participate in either of these consultations please see "how to get involved" below.

How to Get Involved

The consultation workbook can be completed and submitted on-line starting September 15 until November 30, 2009 inclusive.  Please select the following link to start the "Consultation Workbook".

1. Consultation Workbook

Interested parties are encouraged to comment on the consultation workbook by November 30, 2009.

2. Workshops

Stakeholder workshops are planned for the following dates and locations.  If you are interested in participating, please send an e-mail stating your expression of interest to the nearest region that corresponds to you. Please note that space is limited. We will respond to your expression of interest with the workshop details and location.

Location Session Date Contact Express your interest of attending by
Vancouver 2009-10-14 gmp-review-examen-bpf-van@hc-sc.gc.ca 2009-09-30
Edmonton 2009-10-16 gmp-review-examen-bpf-edm@hc-sc.gc.ca 2009-09-30
Toronto 2009-10-27 gmp-review-examen-bpf-tor@hc-sc.gc.ca 2009-09-30
Montreal 2009-10-29 gmp-review-examen-bpf-mon@hc-sc.gc.ca   2009-09-30
Winnipeg 2009-11-03 gmp-review-examen-bpf-win@hc-sc.gc.ca 2009-09-30
Ottawa 2009-11-12 gmp-review-examen-bpf-ott@hc-sc.gc.ca 2009-09-30

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

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