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The primary, globally significant, regulations related to the manufacturing, processing, packing, or holding of drugs include:

 21 Code of US Federal Regulations Part 210 and 211 Current Good Manufacturing Practice Regulations

 EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

The major regulatory bodies or organizations that enforce the regulations or assist in harmonizing international regulatory efforts include:

 US Food and Drug Administration (US FDA, United States)

 European Medicines Agency (EMA, European Union)

 Medicines and Healthcare products Regulatory Agency (MHRA, United Kingdom)

 Health Canada (Canada)

 Brazilian Health Regulatory Agency (ANVISA, Brazil)

 Pharmaceuticals and Medical Devices Agency (PMDA, Japan)

 Therapeutic Goods Administration (TGA, Australia)

 World Health Organization (WHO-International)

 Central Drugs Standard Control Organization (CDSCO, India)

 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-International)

 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) (PIC/S-International)

There are numerous other country-specific bodies, which enforce their own laws related to the manufacturing, processing, packing, or holding of drugs. The reader is encouraged to consult the requirements of their own country's laws and regulations regarding the manufacture of pharmaceuticals.