US FDA Trains 100 Gujarat FDCA Inspectors As Part Of Regulatory Harmonization

Mumbai, 23 March 2019: As a step towards global regulatory harmonization, capacity building and training, Gujarat Food and Drug Control Administration (FDCA) in collaboration with US FDA trained 100 drug inspectors on equipping drug manufacturers on audit -readiness and regulatory compliance. 

The meet between the two regulators is latest in the series of such programmes being ushered in since 2008, which has immensely helped Gujarat drug control officials in understanding regulatory requirements of US FDA. 

Letitia Robinson, country director, OIP, India Office, US FDA met Gujarat FDCA Commissioner Dr H G Koshia as part of US FDA- Gujarat FDCA Regulatory Forum which was intended to usher in dialogue between senior leaderships of the US FDA and Gujarat FDCA to take forward the avenues for future strategic collaboration. 

Informed Gujarat FDCA Commissioner Dr HG Koshia, “The regulatory forum also discussed opportunities for future collaboration in medical products.”

This is the third visit of US FDA officials at Gujarat FDCA office over the past two years to help regulators in capacity building, training, networking, knowledge sharing and compliance.

The visit is significant as domestic industry is also gearing up towards risk based inspections and embracing global standards through upgradation of Schedule M units to WHO -GMP compliant units. 

US FDA visit is an important development as Gujarat has the maximum number of 125 US FDA approved drug manufacturing units. Gujarat also has the distinction of having 28 per cent of drug exports to developed markets and the US.

US-based consulting firm World Compliance Seminars (WCS) has been actively conducting workshops in Gujarat towards audit preparedness of the Indian pharma industry. The workshops have already covered subjects for manufacturers like on how to be prepared or US FDA inspections and how to develop quality culture in Indian pharma companies.

The workshops covered relevant aspects like data integrity and role of data integrity in various functions, current FDA expectations, current trends of FDA, 483 warning letters among others.

US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering had trained around 100 Gujarat FDCA inspectors in the past few years through online modules on cGMP and good laboratory practices (GLP) in collaboration with Gujarat FDCA.

These courses were as per the training imparted to US FDA inspectors which were of immense help to the drug inspectors conducting inspection on the shop floor of a drug facility.

UL also conducted a series of training programmes in 2014 to equip Indian pharma on knowledge, tools and processes for audit readiness. UL Eduneering is a knowledge partner of USFDA on GMP, CGMP and Quality Management System. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad.

The US FDA –CDSCO workshops covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. 

UL Eduneering has the distinction of training 36,000 US FDA drug regulators through its GMP, cGMP, enforcement and Inspection focused courses authored by FDA and developed by UL Eduneering.  Pharmabiz