Consultation opens for the Good manufacturing practices guide: Manufacture of biologics (GUI-0027)
Drug Establishment Licensing Bulletin 141, September 20, 2023
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About the consultation
Annex 2 to the Good manufacturing practices guide - Manufacture of biologics (GUI-0027) was released for a 60-day consultation period from September 20, 2023, to November 20, 2023.
This revised guidance document contains new information, and is adapted from these Pharmaceutical Inspection Cooperation Scheme documents:
- Annex 2B: Guide to good manufacturing practices for medicinal products annexes: Manufacture of biological medicinal substances and products for human use
- Annex 14: Guide to good manufacturing practices for medicinal products annexes: Manufacture of products derived from human blood or plasma
Health Canada is trying to gain international harmonisation of compliance standards by adapting these annexes. We're an active participating member of the Pharmaceutical Inspection Cooperation Scheme. We will continue to update this guidance to align it with their good manufacturing practice standards.
We will write a separate guidance for the Pharmaceutical Inspection Cooperation Scheme Annex 2A: Guide to good manufacturing practices for medicinal products annexes: Manufacture of advanced therapy medicinal products for human use. This will cover guidance for gene, cell and tissue therapies.
This guide is an annex to the following Health Canada guidance document:
These guides are to be read together. They will help you understand and comply with Part C, Division 2, of the Food and Drug Regulations, which is about good manufacturing practices. The requirements of Division 2 apply to biologics, both as bulk process intermediates and in dosage form.
Overview of key changes
We edited the draft guidance document to make it easier to understand. The scope was redefined so that it does not cover advanced therapy medicinal products.
We have also made changes in several sections to make the meaning clearer. For example:
- There are 2 parts to the scope of the document, which cover:
- the stage of manufacture
- the type of product being made
- There are additional details covering manufacturing of biological products.
- Seed lots and cell bank systems are covered as topics.
How to participate
Email us to request the consultation package and submit your comments by November 20, 2023. We will consider all comments when we finalize the guidance document.
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