Good manufacturing practices for medical gases (GUI-0031): Overview
Document change log
Date issued: March 4, 2026
Date implemented: March 4, 2026
Replaces: Good Manufacturing Practices (GMP) for Medical Gases (February 28, 2018)
Disclaimer: This document does not constitute part of the Food and Drugs Act (the act) or its regulations. In the event of any inconsistency or conflict between the act or regulations and this document, the act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the act, the regulations and the applicable administrative policies.
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Purpose
This guide is for people who are required to hold an establishment licence under Part C, Division 1A of the Food and Drug Regulations (regulations). This includes people who work with medical gases as:
- fabricators
- packagers
- labellers
- testers
- distributors
- importers
- wholesalers
- home care providers
This guide will help you understand and comply with Part C, Division 2 of the regulations, which is about good manufacturing practices (GMP).
Whether a licence is required or not, any person storing a medical gas (for example, a wholesaler) must comply with GMP.
For more information on establishment licences or to understand how to comply with GMP requirements in order to get an establishment licence, refer to the following guidance:
Scope
These guidelines apply to medical gases sold by commercial operations. They do not apply to aerosol preparations or to mixtures of solids that are used to generate gases. They also do not apply when fire departments, ambulance services, hospitals or health care facilities that package medical gases for their own use or to administer to a patient.
For the purpose of these guidelines, the following operations are considered a "fabricate" activity:
- producing medical gases through air liquefaction (for example, produced at air separation plants), chemical synthesis, filtration, purification and/or
- producing medical gas mixtures
The following operations are a "packaging/labelling" activity:
- trans filling medical gases at a facility
- curbside filling of medical gases
Introduction
These guidelines replace the:
- Good Manufacturing Practices (GMP) Guidelines for Drug Products (GUI-0001) and
- Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) (GUI-0104) for Medical Gases
Health Canada developed the guidelines in consultation with stakeholders.
Medical gases have unique properties that affect production and handling characteristics. The way the GMP regulations apply to medical gases may be different from other drugs. For example, when manufacturing a medical gas, the resulting gas may be either:
- used as a raw material or
- sold as a bulk drug or a finished packaged product
Note about guidance documents in general
Guidance documents like this one are not legally binding. They are administrative tools to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, ensuring that the rules enforced are fair, consistent and effective across Canada. This document is a guide to assess your compliance with the relevant GMP requirements for medical gases.
To better understand how risk ratings are assigned during inspections, please refer to the following guidance:
Risk classification guide for drug good manufacturing practices observations (GUI-0023)
There is flexibility in how you meet the applicable laws and regulations. If you choose to follow an alternate approach to the principles and practices described in this document, you must provide adequate justification. Alternate approaches should be discussed in advance with the relevant program area. This helps ensure that your approach still meets all legal and regulatory requirements.
Health Canada may request additional information or material, or define conditions not specifically described in this document. These requests help us adequately assess compliance with the act and regulations. We are committed to making such requests only when necessary and to document our decisions clearly and transparently.
This document should be read along with the relevant sections of the regulations and other applicable guidance documents.
If there is a discrepancy between this guidance document and the regulations, the regulations always take precedence.