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GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular, with unexpected contaminants) and mix-ups (for example, false labeling).[3]

Worldwide, there are different official regulatory statements and guidelines, both national and international, for GMP for pharmaceutical (or ‘drug’ or ‘medicinal’) products. They may be regulations (as in the US, Japan, or Korea), directives (as in the EU), guides (as in the UK), codes (as in Australia), or a WHO code (as in many Southeast Asia Countries). Among them, the following stand out as the most influential and most frequently referenced:

  • The US Current Good Manufacturing Practices for Finished Pharmaceuticals regulations (the US cGMPs).[4]
  • The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (the EC GMP Guide).[5]
  • The ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.[6]
  • The World Health Organization (WHO) good manufacturing practices.[7]

The other guidelines and regulations referred by the pharmaceutical manufacturers are as under:

  • Schedule M ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products,’ The Drugs and Cosmetics Act and Rules, India.[8]
  • PIC/S Guide to Good Manufacturing Practice for Medicinal Products.[9]
  • Center for Drug Evaluation and Research (CDER): Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients.[10]


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