The Indian state of Gujarat has hit upon a way to bring its inspectors up to international standards: Hire the company that provides online training to the FDA. Officials at the Gujarat Food and Drug Control Authority (FDCA) will have access to training services from UL EduNeering, the company that has helped the FDA develop its educational program since 1999.
The Gujarat government and UL EduNeering have signed a memorandum of understanding covering the training, the Press Trust of India reports. The goal is to apply the know-how and infrastructure UL has built to help educate 36,000 FDA officials to the training of inspectors at Gujarat FDCA. UL supports training at the FDA and its industry clients through its web-based education platform, which it uses to deliver training on GMPs and other topics.
Officials hope the platform will lead to improved enforcement of GMPs in Gujarat. "UL EduNeering's rich modules of training programs that are followed by FDA would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers in Gujarat," the state's FDCA Commissioner H.G. Koshia said. Such improvements will potentially benefit local patients and help companies avoid costly FDA warnings.
Gujarat has seen its share of FDA slapdowns. Last year FDA put a Sun Pharma facility in the state on its import alert and sent it a warning letter for routinely deleting records of batch failures. A Cadila Pharmaceuticals facility was also chastised for failing to properly investigate dodgy-smelling APIs. And Marck Biosciences joined Sun Pharma on the import alert list.
- read the PTI article