Consultation opens for guidance on good manufacturing practices for medical gases (GUI-0031)
Drug Establishment Licensing Bulletin #149, June 16, 2023
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About the consultation
Health Canada is seeking feedback on our revised guidance document titled Good manufacturing practices for medical gases (GUI-0031).
The consultation period is for 30 days, from June 16 to July 16, 2023.
Overview of key changes
We edited the draft guidance document to make it easier to understand and read by:
- using plain language where possible
- excludes technical terms or those related to regulatory content
- shortening sentences and paragraphs where appropriate
- converting some content to bulleted lists
We updated several interpretations to make the meaning clearer. For example:
- Manufacturing control (Section C.02.012)
- updated recall reporting procedures to include roles and responsibilities
- Quality control department (Section C.02.015)
- expanded computerized system requirements to include data governance
- Packaging material testing (Section C.02.016)
- made our expectations for packaging material specifications clearer
- Records (Sections C.02.020 to C.02.024)
- revised the rationale and interpretations to cover policies for data governance, electronic systems and record retention
- removed expiration dating for stable gases
How to participate
We will consider all comments when we finalize the guidance document.
To participate, please ask us for the consultation package. Please submit your comments by July 16, 2023, by emailing us at hpil-consultation-ipsop@hc-sc.gc.ca.