Guidance Documents

Consultation

General Good Manufacturing Practices

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)
• Good Manufacturing Practices (GMP) for Schedule D Drugs, Part 2, Human Blood and Blood Components

Category IV

• Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs (GUI-0066)

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

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 (August 1, 2009)

• Notice to Stakeholders - New for 2012 Drug Establishment Licence (DEL) Annual Review - Evidence to Demonstrate GMP Compliance of Foreign Sites- [2011-07-29]
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)
  • Cover Letter
• Good Manufacturing Practices - Audit Report Form (FRM-0211)
• Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions
• Good Manufacturing Practices - Foreign Site Submission Form (FRM-0212)
• 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
• Export Certificate (FRM-0176)
• 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 (GMP) for Medical Gases (GUI-0031)
• Medical Gas - Good Manufacturing Practices (GMP) Questions and Answers

Natural Health Products

• Good Manufacturing Practices Guidance Document

Parametric Release

• PIC/S Annex 17: Parametric release

Post-Market Reporting Compliance

• Summary Report of the Post-Market Reporting Compliance Inspections Conducted from September 1, 2005 to March 31, 2008
• Risk Classification of Post-Market Reporting Compliance Observations (GUI-0063)
• Inspection Strategy for Post-Market Surveillance (POL-0041)

Radiopharmaceuticals

• Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)
  • Guidance document: Factors Considered in the Assessment of the Risks involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research involving Humans
• Annex to the Good Manufacturing Practices Guidelines - Good Manufacturing Practices (GMP) for Positiron 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 Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069) [2011-01-28]

Veterinary Drugs

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