50 Drug inspectors are getting trained for Auditing Manufacturing units on cGMP, GLP by Gujarat FDCA

Gujarat Food and Drug Control Administration (FDCA) trained 50 drug inspectors mainly for auditing the manufacturing units. The training was done to detect the faulty medical devices and sub-standard drugs in line. The training was imparted to US Food and Drug Administration (FDA) inspectors through collaboration with US-based Underwriters Laboratories. Such training will help the drug inspectors in analyzing the drug samples and devices.

During this training, the drug inspectors cleared 50 new online modules on cGMP (current good manufacturing) and GLP (good laboratory practices) with good scoring as reported by an official associated with the development. The training is an initiative of a strategic partnership for knowledge sharing with UL.

Gujarat FDCA has earlier rolled out 50 new courses and adopted 150 courses on GMP. These training sessions are mainly for the drug inspectors in collaboration with the UL. Underwriters Laboratories is offering around 700 courses out of which 125 courses are authorized by the U.S Food and Drug Administration (FDA).

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

Gujarat is known today for having the highest number of licensed medical device units. Around 170 licensed medical device units are under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in India.

CLAA is basically formed to monitor the regulatory activities that are related to granting of and manufacturing the license for hi-tech medical devices in the country. CLAA ensures the devices that are manufactured in India follow and the standard requirement set by the Government to ensure efficacy, safety and quality of the devices.

Earlier this year, around 100 drug inspectors have already been trained on medical devices as a part of the Gujarat FDCA’s collaboration with Abbott India. This training was a part of the strategic partnership for knowledge sharing at the Vibrant Gujarat Global Summit (VGGS) organized at Gandhinagar.

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