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”.
- GMP News: The GMP Inspectorate in Russia: FSI SID & GP is the authority for conducting GMP inspections of foreign medicine manufacturers
- GMP News: Organisation and procedure for inspections of foreign manufacturers
- GMP News: New NAO Severnaya Zvezda manufacturing facility
- GMP News: GMP Conference: The Main Event in the Russian Pharmaceutical Market
- Radio Sputnik: «There were no obstacles despite political tensions»