Good manufacturing practices
Health Canada is supporting drug establishment licence holders by providing temporary measures due to COVID-19. For more information, please visit DEL and GMP temporary measures due to COVID-19.
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What are good manufacturing practices
Good manufacturing practices (GMP) ensure drugs meet the appropriate quality standards for their intended use before they are sold.
To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package/label, test, distribute, import or wholesale drugs. 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 with these requirements, we have developed a series of guides and other related documents.
Drug and health product inspections
Health Canada regularly inspects companies that fabricate, package/label, test, import, distribute or wholesale drugs for the purpose of sale in Canada. This helps ensure drugs sold to people in Canada are safe and meet good manufacturing practices.
Health Canada manages a GMP inspection program to verify industry complies with the regulations. To learn more about the drug inspections we conduct each year, you can browse the Drug and health product inspections database.
Information about emerging issues identified through our GMP inspection program is available to the public. For a regular snapshot of the potential health and safety issues we monitor, please visit:
These potential issues relate to companies that fabricate, package/label, test, import, distribute or wholesale drugs for sale in Canada.
For general questions about good manufacturing practices, your regulatory obligations and questions on domestic and foreign GMP inspections, email us at: firstname.lastname@example.org.
- Drug establishment licences
- Good manufacturing practices guide for drug products (GUI-0001)
- Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104)
- Q9: Quality Risk Management - International Council for Harmonisation
- Post-notice of compliance changes: Quality document - guidance document
- Alternate sample retention site guidelines (GUI-0014)
- Chemical entity products/quality
- Drug establishment good manufacturing practices - Pre-application package (importers, distributors and wholesalers)
- Guidance on drug establishment licences (GUI-0002)
- Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Risk classification guide for drug good manufacturing practices observations (GUI-0023)
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
- Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, Biological Drugs (GUI-0027)
- Annex 3a to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule C Drugs (GUI-0026)
- Annex 3b to the Good Manufacturing Practices Guidelines – Positron Emitting Radiopharmaceuticals (PER’s) (GUI-0071)
- Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines – Veterinary Drugs (GUI-0012)
- Annex 7 to the Good manufacturing practices guide – Selected non-prescription drugs (GUI-0066)
- Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050
- Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines – Drugs Used in Clinical Trials (GUI-0036)
- Annex 17, Parametric Release (PIC/S) - Guide to Good Manufacturing Practice for Medicinal Products Annexes
- Good manufacturing practices for medical gases (GUI-0031)
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