Ingredients News - Gujarat FDCA trains 50 drug inspectors for auditing manufacturing units on cGMP, GLP


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Gujarat FDCA trains 50 drug inspectors for auditing manufacturing units on cGMP, GLP

Shardul Nautiyal, Mumbai September 29 , 2017

The Gujarat Food and Drug Control Administration (FDCA) has trained 50 drug inspectors to detect faulty medical devices and sub-standard drugs in line with the training imparted to US Food and Drug Administration (FDA) inspectors through a collaboration with US-based Underwriters Laboratories (UL) recently. This would help drug inspectors in analysing drug samples, devices and auditing manufacturing units.

The drug inspectors cleared 50 new online modules on current good manufacturing (cGMP) and good laboratory practices (GLP) with good scoring, said an official associated with the development. This initiative is part of strategic partnerships for knowledge sharing with UL which is a global safety consulting and certification company.

Gujarat FDCA had earlier rolled out 50 new courses and adopted 150 courses on GMP to train drug inspectors in collaboration with UL. UL is offering about 700 such courses of which 125 courses are authored by the US FDA.

Such online courses is of immense help to the drug inspectors who conduct inspection on the shop floor of a drug facility. These courses are as per the training imparted to US FDA inspectors towards increasing compliance in cases related to spurious drugs and faulty medical devices.

Gujarat today boasts of having the highest number of 170 licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country.

CLAA scheme was formed to oversee the regulatory activities related to grant of manufacturing license for hi-tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.

The state drug regulator and bioMérieux, a 115 years old French Company is also going to start training programmes on microbiological testing technologies and applications following an MoU to cater to the regulatory requirements of domestic and export markets.

Merck had in the past trained 25 Gujarat FDCA officers on GLP through a hands-on training programme to streamline quality assurance protocols and SOPs in labs.

Around 100 drug inspectors have already been trained on medical devices as part of the Gujarat FDCA's collaboration with Abbott India as part of strategic partnership for knowledge sharing at the Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar earlier this year.

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