ARCHIVED - Consultation: Draft Guide for the Risk Classification of Observations Made During Inspections of Blood Establishments (Revised)


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. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

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.

Comments are Requested on the Following Draft Document:

  • Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061)

This document provides guidelines for classification of the observations noted during the inspections of blood establishments based on their risk.

This guidance document covers blood and blood components, to which Part C, Division 2 of the Food and Drug Regulations applies and is based on the current edition of the GMP. This guidance document also covers source plasma as it relates to Part C, Divisions 2 and 4 of the Food and Drug Regulations.

The Appendix attached to this document provides examples of situations or observations related to each category of risk. Please note that the list of situations or observations in the appendix is not exhaustive and that additional situations or observations may be added where appropriate.

It is important to note that this guide corresponds to the current regulatory framework. A new regulatory framework is being developed for blood and blood components and once in place, this guide will be revised accordingly.

Below, please find information on how to provide comments on this document.

How to Get Involved

This consultation is open for comments starting July 17, 2009 until September 30, 2009. To request a copy of this document: Interested stakeholders who wish to provide comments can request an electronic copy of the document listed below via email at:

To request an alternate format of the document please contact us via e-mail, phone, fax or by mail.

Blood, Tissues, Organs and Xenografts Unit (BTOX)
Health Products and Food Branch
250, Lanark Avenue
Ottawa, Ontario K1A 0K9
Phone: 613-954-5011
Fax: 613-946-5636

Comments are Requested on the Following Draft Document:

  • Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061)

Comments received from stakeholders and interested parties will be reviewed after the 75 day comment period.

Interested parties are encouraged to provide comments and suggestions by September 30, 2009 on the above document.

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

Yours truly
Original signed by
Diana Dowthwaite
Director General

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