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

• Regulations for Implementation of the Drug Administration Law of the People’s Republic of 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

Japan – Pharmaceuticals and Medical Devices Agency

• Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative Translation VER. 09092005) [GMP] (24 December 2004)