Guidance Documents – Good Manufacturing Practices

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)

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• Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products [2020-02-20]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• Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) [2011-09-23]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]

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) [2018-10-01]
• 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

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)

Biologics / Blood

• Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs) (GUI-0027)

Non-Prescription Drugs

• Annex 7 to the Good manufacturing practices guide for drug products-Selected non-prescription drugs

Clinical Trials - Manufacturing GMPs

• Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)

Compounding

• Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) [2009-01-26]

Computers

• PIC/S Annex 11: Computerised Systems

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)
  • Cover Letter
  • Notice to Stakeholders - New for 2012 Drug Establishment Licence (DEL) Annual Review - Evidence to Demonstrate GMP Compliance of Foreign Sites [2011-07-29]
  • Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation [2012-08-29]
• 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)

Importation / Exportation

• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported
• Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUIDE-0067)

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

• Good Manufacturing Practices Guidance Document

Parametric Release

• PIC/S Annex 17: 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]

Veterinary Drugs

• Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012)