REGULATORY AUTHORITIES.Regulatory Authorities world wide demand that Medical Device manufacturers establish and document quality systems to ensure that all of their manufacturing processes are validated as being consistently capable of producing product to within the required specifications. These quality systems requirements are known as good manufacturing practices (GMP’s) and the on-going continuation of them is known as ‘continued Good Manufacturing Practices (cGMP’s). For further details regarding the major worldwide regulators: Australia - Therapeutic Goods Administration Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) Australian Code of GMP for Human Blood and Tissues (24 August 2000) Canadian Good Manufacturing Practices for Drugs (Part C Division 2 of Food and Drug Regulations) 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 Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative Translation VER. 09092005) [GMP] (24 December 2004) United States - Food and Drug Administration GMP Regulations 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs - (As of 1 April 2009) [PDF ( 21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals- (As of 1 April 2009) [PDF ( 21 CFR Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs - Federal Register Notice Introducing This Regulation 21CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (As of 1 April 2008) [PDF ( 21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components (As of 1 April 2008) [PDF ( 21 CFR Part 820 - Quality System Regulation (As of 1 April 2008) [PDF] 21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (As of 1 April 2008) [PDF] WHO Good Manufacturing Practices
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