Notice of publication: Good manufacturing practices guidelines for active pharmaceutical ingredients
On February 10, 2022, the Health Product Compliance Directorate posted Good manufacturing practices guidelines for active pharmaceutical ingredients - (GUI-0104). It's an update to the previous guide.
Changes include new information:
- about re-testing of active pharmaceutical ingredients (APIs)
- to clarify analytical test methods
- to clarify that the scope includes cannabis APIs
- about re-packaging, testing and sampling requirements
Changes also include:
- added definitions related to:
- cannabis APIs
- antimicrobial resistance and antimicrobial agents
- updated information on:
- stability testing and API intermediates
- to align with applicable sections of the current Good manufacturing practices guide for drug products (GUI-0001)
- an expanded scope to include veterinary APIs
- language that's easier to read and understand
- updated interpretations to align with internationally harmonized standards (ICH Q7)
We will provide details for an information session to review the changes to the guidelines in a future DEL bulletin.
If you have any questions, contact us at api.questions-ipa@hc-sc.gc.ca.