New version of Annex 2 to the Good manufacturing practices guide – Manufacture of biologics (GUI-0027)

Drug Establishment Licensing Bulletin 179, July 4, 2024

On July 4, 2024, Health Canada updated the following guidance document:

• Annex 2 to the Good manufacturing practices guide – Manufacture of biologics (GUI-0027)

This revised guide takes effect immediately, replacing the November 2010 version and is an annex to the following guidance document:

• Good manufacturing practices guide for drug products (GUI-0001)

These guides are meant 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 (GMP).The requirements of Division 2 apply to biologics, both as bulk process intermediates and in dosage form.

This revised guidance document contains new information and is adapted from these Pharmaceutical Inspection Cooperation Scheme documents:

• Annex 2B: Manufacture of biological medicinal substances and products for human use
• Annex 14: 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.

Key changes to the revised document

We have updated GUI-0027 to reflect changes to the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licenses and Finished Product Testing).

We edited the 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.

We also added a reference section that lists biologic specific references not available in the main guidance document (GUI-0001).

Contact us

If you have questions, you should contact the Health Product Inspection and Licensing Division of the Regulatory Operations and Enforcement Branch. Email us at drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.