. Collaboration between US FDA and Gujarat FDCA to Implement Joint Project | IGMPI

  • Institute of Good Manufacturing Practices India
  • Global accredited training & certification provider
  • Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
  • Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
  • Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
  • Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
  • Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research

Collaboration between US FDA and Gujarat FDCA to Implement Joint Project

Among top three aspects for collaboration- knowledge sharing, capacity building and raising compliance levels, the Gujarat Food and Drug Control Administration (FDCA) is planning to meet US Food and Drug Administration (FDA) officials. As per national data, Gujarat accounts for 28% of Drug exports to various developed markets. In a recent incidence, a US FDA cyber notice was recently issued to one of the Gujarat based manufacturers for supplying spurious herbal drugs to the US market. This prompted Gujarat FDCA totake action and sent the testing samples at Vadodara testing lab. Gujarat FDCA inspectors have been trained through online courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with US-based Underwriters Laboratories (UL) as part of strategic partnerships for knowledge sharing. UL is a global safety consulting company offering about 700 such courses of which 125 courses are co-authored by the US FDA. This collaboration between 2 regulators facilitatesGujarat’s FDCA’s understanding in regulatory requirements of US FDA. Gujarat saw an increase in pharma exports in the past one decade with US$ 3,060 million worth of exports in 2016 from a quantum of exports worth US$ 562 million in 2006.