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April 2026Health Canada has updated GUI-0005 guidance to help drug establishments prepare a compliant Site Master File (SMF) in line with Good Manufacturing Practices (GMP) and the Food and Drug Regulations.
The SMF supports GMP inspections and regulatory compliance for activities such as drug fabrication, packaging, labeling, and testing. The latest update (10-Apr-2026) includes new Appendix requirements (Section 4.10).
The document outlines key SMF components, including quality management systems, production processes, quality control, supplier management, and risk management practices.
It also covers distribution systems, complaint handling, product defects, and recall procedures, ensuring full lifecycle compliance.
The SMF should be concise (25–30 pages plus appendices) and regularly updated. Required appendices include GMP certificates, manufacturing authorizations, organizational charts, and equipment lists.
This guidance helps ensure consistent GMP implementation, inspection readiness, and regulatory alignment across Canada.
Region: Canada
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