GMP Guidelines
Australian GMP Guidelines
- Questions & answers on the code of good manufacturing practice for medicinal products
- Technical Guidance on the Interpretation of Manufacturing Standards for Supplier Qualification
Canadian GMP Guidelines
- Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs) (GUI-0027)
- Consultation: Draft Documents for Drug Good Manufacturing Practices Inspection Program (7 August 2009)
- Consultation on Good Manufacturing Practices- Inspection Program Review (26 January 2011)
- Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
- GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
- 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)
- Good Manufacturing Practices (GMP) for Schedule D Drugs, Part 2, Human Blood and Blood Components
- Good Manufacturing Practices (GMP) Guidelines (4 March 2011)
- Guidance Document – Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)
- Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) Cover Letter
- GUIDE-0023: Risk Classification of GMP Observations, 2003 edition
- Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review (26 January 2011)
- Veterinary Drugs Annex to Current Edition of the Good Manufacturing Practices Guidelines
European Union GMP Guidelines
- EudraLex – Volume 4: Good manufacturing practice (GMP) Guidelines
- Q&A: Good Manufacturing Practice (GMP)
Japanese GMP Guidelines
US FDA GMP Guidelines
- Center For Drug Evaluation and Research
- Center For Veterinary Medicine
- Center For Biologics Evaluation and Research
- Center For Device and Radiological Health
