Notice of publication: Good Manufacturing Practices for medical gases (GUI-0031)
Drug Establishment Licensing Bulletin 173, March 4, 2026.
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About the publication
On March 4, 2026 Health Canada published the following guidance document:
This document takes effect immediately.
The updated guidance document follows a 30-day consultation period that took place June 16 to July 16, 2023. We reviewed the feedback from stakeholders and implemented changes where applicable.
Learn more:
Since October 1, 2018, Health Canada's Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) replaced the Good manufacturing practices (GMP) guidelines for drug products (GUI-0001) and Good manufacturing practices (GMP) for active pharmaceutical ingredients (API) (GUI-0104) as they pertain to medical gases. These guidelines were developed by Health Canada in consultation with stakeholders and apply specifically to medical gases sold by commercial operations.
Overview of key changes
This revised guidance document contains new information to make the document clearer and align with current industry practices.
We made the following changes:
- updated recall reporting procedures to include roles and responsibilities
- expanded computerized system requirements to include data governance
- clarified our expectations for packaging material specifications
- revised the rationale and interpretations to cover policies for data governance, electronic systems and record retention
- removed expiration dating for stable gases
How to contact us
If you have any questions, we invite you to contact the Health Product Inspection and Licensing Division (HPIL) of the Regulatory Operations and Enforcement Branch (ROEB).