Health Canada · GMP
Health Canada GMP guides
The GMP guide documents (GUI series) published by Health Canada, listed by publication date. These documents set the standards for drug GMP inspections and Establishment Licence operations. Always check the official source for legal status and the latest version.
- GUI-0005 Explanatory notes for drug establishments on the preparation of a site master file
- GUI-0031 Good manufacturing practices for medical gases
- GUI-0036 Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials
- GUI-0158 Good manufacturing practices guide for natural health products
- GUI-0080 How to demonstrate foreign building compliance with drug good manufacturing practices
- GUI-0039 Drug, natural health product and biocide recall guide
- GUI-0127 Applications and service standards for drug establishment licences
- GUI-0074 Overview: Guide to validation of terminal sterilization process of drugs
- GUI-0012 Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs
- GUI-0026 Annex 3A to the Good manufacturing practices guide - Schedule C drugs
- GUI-0027 Annex 2 to the Good manufacturing practices guide - Manufacture of biologics
- GUI-0066 Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs
- GUI-0119 Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs
- GUI-0104 Good manufacturing practices guidelines for active pharmaceutical ingredients
- GUI-0050 Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050
- GUI-0028 Cleaning validation guide
- GUI-0029 Guide to validation - drugs and supporting activities
- GUI-0071 Annex 3B to the Good manufacturing practices guide - Positron-emitting radiopharmaceuticals
- GUI-0069 Guidelines for environmental control of drugs during storage and transportation
- GUI-0023 Risk classification guide for drug good manufacturing practices observations
- GUI-0001 Good manufacturing practices guide for drug products
- GUI-0002 Guidance on Drug Establishment Licences
- GUI-0024 Guidance on obtaining electronic certificates of pharmaceutical products and good manufacturing practices
- GUI-0014 Guidance Document Alternate Sample Retention Site Guidelines
- GUI-0072 Cover Letter - Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's Access to Medicines Regime: Guide-0072
- GUI-0067 Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership
