Good manufacturing practices for medical gases (GUI-0031) - Summary

Overview

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. They were developed by Health Canada in consultation with stakeholders.

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 package medical gases for their own use or administration to a patient.

Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

Health Canada inspects establishments to assess their compliance with the Food and Drugs Act and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.

Who this guide is for

This guide is for people who work with drugs as:

• fabricators
• packagers
• labellers
• testers
• distributors
• importers
• wholesalers
• home care providers

In this guide

• About this document
  • 1. Purpose
  • 2. Scope
  • 3. Introduction
• About quality management
  • 4. Pharmaceutical quality system
    • Guiding principles
    • Pharmaceutical quality system
    • Good manufacturing practices for drugs
    • Quality control
    • Quality risk management
• Guidance
  • 5. Regulations
    • Division 2 - Good manufacturing practices
      • C.02.002
    • Sale
      • C.02.003
      • C.02.003.1
      • C.02.003.2
    • Use in fabrication
      • C.02.003.3
    • Premises
      • C.02.004
    • Equipment
      • C.02.005
    • Personnel
      • C.02.006
    • Sanitation
      • C.02.007
      • C.02.008
    • Raw material testing
      • C.02.009
      • C.02.010
    • Manufacturing control
      • C.02.011
      • C.02.012
    • Quality control department
      • C.02.013
      • C.02.014
      • C.02.015
    • Packaging material testing
      • C.02.016
      • C.02.017
    • Finished product testing
      • C.02.018
      • C.02.019
    • Records
      • C.02.020
      • C.02.021
      • C.02.022
      • C.02.023
      • C.02.024
      • C.02.024.1
    • Medical gases
      • C.02.030
• Appendices
  • Appendix A - Glossary
    • Acronyms
    • Terms
  • Appendix B - Frequently asked questions
  • Appendix C -References

View complete guide

Download PDF (580 KB, 68 pages)

Details and history

• Published: February 28, 2018
• Implementation: October 1, 2018
• Consulted: January 18, 2017 - April 18, 2017

For assistance

By email: GMP_Questions_BPF@hc-sc.gc.ca

Service standards: We answer to mail within 10 business days. If we can't answer your question right away we will send you an estimate date.