New version of Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026)

Drug Establishment Licensing Bulletin 139, July 4, 2024

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

• Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026).

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

• Good manufacturing practices guide for drug products (GUI-0001)
• Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104)

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 on good manufacturing practices (GMP).

Key changes to the revised document

We have updated GUI-0026 to reflect changes to the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licenses and Finished Product Testing).

The original title of the guide was Guidance document Annex 3 to the current edition of the good manufacturing practices guidelines - Schedule C drugs (GUI-0026).The new title is Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026).

We edited the guidance document to make it easier to understand, including:

• Updates to the definitions and acronyms
• Changes to the order of the first 3 sections
• Addition of a table to explain where GMP may begin and end for both finished dosage forms and active ingredients
• Updates to the references to theGood manufacturing practices guide for drug products (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.