Guidance Documents – Good Manufacturing Practices
On this page
- Active Pharmaceutical Ingredients
- Biologics / Blood
- Canada's Access to Medicines Regime (CAMR)
- Clinical Trials - Manufacturing GMPs
- Computers
- Compounding
- Consultation
- Establishment Licences
- Foreign Sites
- General Good Manufacturing Practices
- Good Pharmacovigilance Practices (GVP)
- Importation / Exportation
- Medical Gases
- Natural Health Products
- Non-Prescription Drugs
- Parametric Release
- Radiopharmaceuticals
- Transport
- Validation
- Veterinary Drugs
Active Pharmaceutical Ingredients
- Consultation on the Atypical Active Pharmaceutical Ingredients List [2016-12-02]
- Active Pharmaceutical Ingredients - Questions and Answers
- Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104)
Biologics / Blood
Canada's Access to Medicines Regime (CAMR)
- Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
- Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's Access to Medicines Regime (GUIDE-0072)
Clinical Trials - Manufacturing GMPs
Computers
Compounding
Consultation
- Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products [2020-02-20]
- Consultation and Notice to Stakeholders: Release of Guidance Documents for Consultation: Various good manufacturing practices and drug establishment licensing guidance documents [2017-01-18]
- Consultation: Invitation to Participate in the Survey for ICH Q7 Constituencies Input for Development of a Question and Answer Document [2013-02-15]
- Consultation: Cleaning Validation Guidance (GUI-0028) [2011-12-16]
- Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) [2011-09-23]
- Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection Program [2011-07-08]
- Notice to Stakeholders - Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
- Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review [2011-01-26]
- Good Manufacturing Practices (GMP) - Establishment Licence (EL) Information Sessions [2010-03-18]
- Consultation on Good Manufacturing Practices- Program Review [2009-09-15]
- Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program (GUI-0001 Related) [2009-08-07]
- Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program [2009-08-07]
Establishment Licences
- Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
- GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
Foreign Sites
- Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)
- Good Manufacturing Practices - Audit Report Form (FRM-0211)
- Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions
- Good Manufacturing Practices - Request for an Inspection of a Foreign Site Form (FRM-0213)
- Good Manufacturing Practices - Foreign Site Inspection Services Agreement Form (FRM-0214)
General Good Manufacturing Practices
- Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050 [2021-08-10]
- Good manufacturing practices guide for drug products (GUI-0001) [2020-07-01]
- Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs (GUI-0119) [2023-09-11]
- Risk classification guide for drug good manufacturing practices observations (GUI-0023) [2018-02-28]
- Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005) [2020-07-17]
- New Presentation of Official Documents Requiring Sign of Authenticity - Paper and Seal
Good Pharmacovigilance Practices (GVP)
- Notice to Stakeholders: Name change for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP)
- Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
- Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)
- Inspection Strategy for Good Pharmacovigilance Practices for Drugs (POL-0041)
- Summary Report of the Post-Market Reporting Compliance Inspections Conducted from September 1, 2005 to March 31, 2008
Importation / Exportation
Medical Gases
- Letter to Associations Regarding Transfilling of Medical Gases
- Good manufacturing practices for medical gases (GUI-0031) effective on [2018-10-01]
Natural Health Products
Non-Prescription Drugs
- Natural health products good manufacturing practices pre-inspection package
- Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs (GUI-0066)
Parametric Release
Radiopharmaceuticals
- Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)
- Annex to the Good Manufacturing Practices Guidelines - Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs) (GUIDE-0071)
- Guidance Document Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule C Drugs (GUI-0026)
Transport
- Guidelines for environmental control of drugs during storage and transportation (GUIDE-0069) [2020-08-24]
Validation
- Cleaning validation guide (GUI-0028)
- Guide to validation – drugs and supporting activities (GUI-0029) - Summary
- Guide to validation of terminal sterilization process of drugs (GUI-0074)
Veterinary Drugs
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