GMP

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.


GMP Guidelines

Australian GMP Guidelines

  • Questions & answers on the code of good manufacturing practice for medicinal products

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
  • Consultation on Good Manufacturing Practices- Inspection Program Review
  • 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
  • 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
  • Veterinary Drugs Annex to Current Edition of the Good Manufacturing Practices Guidelines

European Union GMP Guidelines

  • Q&A: Good Manufacturing Practice (GMP)

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

World Health Organization Guidelines

  • GMP Questions and Answers
  • Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials