Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031)

Background

The draft guidelines outlined in Good Manufacturing Practices for Medical Gases (GUI-0031), state the generally applicable principles and practices that are acceptable to the Inspectorate and that should facilitate compliance of fabricators, packagers/labellers, distributors, importers, and home care providers of medical gases with Division 2, Part C of the Food and Drug Regulations on Good Manufacturing Practices (GMP).

This guidance document was revised to reflect the current regulatory environment and to clarify certain aspects that have relevance to the companies dealing with medical gases. Due to their unique production and handling characteristics, the application of the GMP Regulations to medical gases may be different from their application to other pharmaceuticals, thus the interpretations provided in the main GMP Guidelines are replaced by those given in this document for medical gases.

The GMP guidelines are available on Health Canada's Compliance and Enforcement website.

Information on the Document:

The document being consulted on Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031), has been reviewed as part of the Inspectorate program's quality management process and has been amended. Highlights of the major changes to the document are as follows.

• The inclusion of a description of the Annual Product Quality Review (APQR) requirements.
• The inclusion of requirement for source gas to be of Compendial Grade.
• The updated descriptions of required Quality Agreements.
• Other changes based on the new version of the Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001).

How to Get Involved and Deadline

The consultation period is open for comment for 90 days, starting September 23, 2011 until December 22, 2011.

To request the document: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of the document to GMP_questions_BPF@hc-sc.gc.ca.

Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.

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 December 22, 2011 on the above document.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.
Any questions or comments should be addressed to GMP_questions_BPF@hc-sc.gc.ca.

Yours truly

Diana Dowthwaite
Director General