These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders.

Introduction Interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations Developed by Health Canada in consultation with stakeholders Written to harmonize …

These guidelines interpret the requirements for manufacturing sterile drugs in Part C, Division 2, section C.02.029 of the Food and Drug Regulations (regulations).

Nov 10, 2025 · Navigate Regulatory Complexity with Confidence.

During these inspections, we verify compliance with GMP (Part C, Division 2 of the Food and Drug Regulations). This is a requirement for issuing a drug establishment licence. To help industry comply …

Jan 22, 2025 · The foundation of Health Canada’s GMP requirements lies in Part C, Division 2 of the Food and Drug Regulations. These guidelines apply to the production, packaging, labeling, testing, …

No person shall use an active ingredient in the fabrication of a drug unless it is fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

Apr 1, 2022 · The requirements outlined in Part C, Division 2 (Good Manufacturing Practices) of the Food and Drug Regulations and the interpretive guidelines on the subject published by Health Canada.

1A (Establishment Licences) and Divisions 2 to 4 (Good Manufacturing Practices) of the Regulations. 3.0 Scope This policy applies to persons and activities subject to Drug GMP and DEL requirements …

May 15, 2025 · Health Canada’s GMP requirements are specified in Part C, Division 2 of the Food and Drug Regulations, with additional guidance in Annex 2 for biological products.