Annex 4 to the current edition of the good manufacturing practices guidelines for veterinary drugs (GUI-0012)
Drug Establishment Licensing Bulletin 172, March 26, 2024
On March 25, 2024, the Health Product Compliance Directorate posted the following guidance document:
This guide 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, which is about good manufacturing practices (GMP).
Key changes to the revised document
The guidance document has been edited to make it easier to understand.
We have also made changes in several sections to make the meaning clearer. For example:
- if the guide applies to the relevant veterinary drugs that are subject to a veterinary monograph published on a Health Canada webpage (all sections)
- in the veterinary drugs section, changes made in the premises, sanitation and stability parts
- in the non-sterile, non-prescription veterinary drugs section, changes made in the sanitation, raw material testing, manufacturing control, quality control department, finished product testing and stability testing parts
- in the veterinary premix section, changes made in the premises, equipment, personnel, sanitation, raw material testing, manufacturing control and stability testing parts
We also added a reference section that lists veterinary 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.