Australia
Canada
- Health Canada
- Submission Filing Requirements - Good Manufacturing Practices GMP/Establishment Licences (EL)
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
China
- China Food and Drug Administration
- Regulations for Implementation of the Drug Administration Law of the People's Republic of China
Europe
India
- Central Drug Standard Control Organization
- Schedule M - Good Manufacturing Practices and Requirements of Premises, Plant and Equipment For Pharmaceutical Products
Japan
United States
- Food and Drug Administration GMP Regulations
- 21 CFR Part 4 - Current Good Manufacturing Practice Requirements for Combination Products (As of 1 April 2013)
- 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (As of 1 April 2013)
- 21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals- (As of 1 April 2013)
Historical preambles announcing changes and comments regarding 21 CFR Parts 210 and 211. - 21 CFR Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs - (As of 1 April 2013)
- 21CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (As of 1 April 2013)
Historical preambles announcing changes and comments regarding 21 CFR Part 110 - 21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components (As of 1 April 2013)
Historical preambles announcing changes and comments regarding 21 CFR Part 606 - 21 CFR Part 820 - Quality System Regulation (As of 1 April 2013)
Historical preambles announcing changes and comments regarding 21 CFR Part 820 - 21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (As of 1 April 2013)
Historical preambles announcing changes and comments regarding 21 CFR Part 111