GMP Regulations for Friday the 13th
Happy Friday the 13th! Remember, if you need a GMP or Quality specialist who knows the regulations below then don’t be scared. Call MEIRxRS.
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)
- 21 CFR Part 606 – Current Good Manufacturing Practice For Blood and Blood Components (As of 1 April 2013)
- 21 CFR Part 820 – Quality System Regulation (As of 1 April 2013)
- 21 CFR Part 111 – Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (As of 1 April 2013)
Australia – Therapeutic Goods Administration
- Australian codes of good manufacturing practice – current status ~dead link~
- Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002)
- Australian Code of GMP for Human Blood and Tissues (24 August 2000)
Canada – Health Canada
- Canadian Good Manufacturing Practices for Drugs (Part C Division 2 of Food and Drug Regulations) ~dead link~
China
European Union – European Medicines Agency
- Eudralex Volume 4 – Good Manufacturing Practice Guidelines
- Directive 2003/94/EC for medicinal products for human use and investigational medicinal products for human use
India – Central Drug Standard Control Organization
- ~link broken~ Schedule M – Good Manufacturing Practices and Requirements of Premises, Plant and Equipment For Pharmaceutical Products
