Consultation - Good manufacturing practices guide: Manufacture of biologics (GUI-0027)

From: Health Canada

This revised guidance document contains new information. The information is being adapted from the following Pharmaceutical Inspection Cooperation Scheme (PICS) 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

Join in: how to participate

Send an email to hpil-consultation-ipsop@hc-sc.gc.ca to ask for the consultation package and submit your comments by November 20, 2023. We will consider all comments when we finalize the guidance document.

Focus of this consultation

Health Canada is adapting these annexes to align our compliance standards with the international good manufacturing practice standards. As an active participating member of PICS, we will continue to update this guidance to align it with their standards.

We will write a separate guidance for the PICS 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:

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

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.

Key changes in the draft guidance

We edited the draft guidance document to make it easier to understand.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 made
• There are additional details covering manufacturing of biological products.
• Seed lots and cell bank systems are covered as topics.

Contact us

Health Product Compliance Directorate (HPCD)
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Ottawa ON  K1A 0K9
Email: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca