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Lapses in Global GMP compliance and enforcement. Impact on FPPs

The article provides a brief overview of the scope of responsibility of Regulatory Authorities whose employees are members of the ISPE, as well as a comparative analysis of GMP rules of: PIC/S, WHO, FDA, CFDA, CDSCO and FSI “State Institute of Drugs and Good Practices”.

 

Lapses in Global GMP compliance and enforcement