WORLDWIDE REGULATIONS OF GMP, INITIATION AND APPLICATIONS

If GMP is not followed, drug is adulterated

     

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     Compliance with GMP is a necessary condition for marketing authorization, in other words domestic and foreign producers of pharmaceutical companies cannot sell or market their drugs without it in the West and North. There is no stage of drug life cycle which is not regulated and documented whether it is the laboratory phase of a new molecular entity discovery, testing in clinical trials, or the licensing, manufacturing, and distribution. according to new industry standards, Drugs are considered to be adulterated, if GMPs are not met. here we discuss about worldwide regulations for GMP, how it initiated and applied. 

•   First version of GMP guidelines for manufacturing, processing, packing, or holding finished      pharmaceuticals was introduced by US FDA in 1963 

•   Four years later, the WHO version of GMPs was prepared by a group of consultants at the         request of the Twentieth World Health Assembly (WHO 2004). From then, there were several   amendments and extensions of the guidelines and many countries developed their own GMP   guidelines which are based on the WHO guidelines. 

•   ln   1991, GMP standards were harmonized at the EU level.
•     ln 1999, the  lnternational Conference on Harmonization, a common project of the EU, Japan and the US,  brought GMPs for Active Pharmaceutical Ingredients, which apply in signatory countries, the EU,  Japan and the US, and also in other countries (e.g., Australia, Canada, Singapore).

       The enforcement of GMPs rests on individual states: in the US, the responsibility is                      with  National Regulatory Agencies.