- Australian Good Manufacturing Practice
Guidance Documents
- Questions & answers on the code of good manufacturing practice for medicinal products (16 September 2010)
This document provides guidance on the interpretation of GMPs for medicinal products.
Other
- Request form for GMP or Quality Systems certificates
Forms for requesting: GMP Certificate of Compliance (medicinal product manufacturer); Certified copy of GMP Certificate of Compliance Quality Systems Certificate (medical device manufacturer); Certified copy of Quality Systems Certificate; Mutual Recognition Certificate (MRA)
- Questions & answers on the code of good manufacturing practice for medicinal products (16 September 2010)
- Canadian GMP Resources
Guidance Documents
- Guidance Document Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (3 March 2009)
- Medical Gas - Good Manufacturing Practices (GMP) Questions and Answers (July 2007)
- Good Manufacturing Practices (GMP) Guidelines - 2009 Edition (GUI-0001)
- GMP Questions and Answers
- US GMP Resources
- International GMP Resources
International Conference on Harmonization
- ICH Guidelines
ICH publishes guidelines on topics concerning safety, quality, efficacy, and multidisciplinary topics.
World Health Organization
- WHO GMP page
This page provides WHO's GMP standards and guidelines for a variety of products.
- ICH Guidelines
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