Express Pharma

GMP: A continous process

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Vinod Arora, Principal Advisor Institute of Good Manufacturing Practices India–IGMPI, gives insights on ways to enable cGMP to assure safety and efficacy of drug products

Good Manufacturing Practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorisation. GMP represents minimum standards that are necessary. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

GMP guidelines

The first version of GMP guidelines for manufacturing, processing, packing or holding finished pharmaceuticals was introduced by the US FDA in 1963. Four years later, the WHO version of GMP was prepared by a group of consultants at the request of the 20th World Health Assembly. From then there were several amendments and extensions of the guidelines and many countries developed their own GMP guidelines which are based on WHO guidelines

  • WHO GMP Guidelines