bioMérieux to equip Gujarat FDCA on auditing drug quality

To raise the bar ahead in terms of drug quality, bioMérieux will train Gujarat Food and Drug Control Administration (FDCA) inspectors to check contamination in medicines imported and exported as per global regulatory requirements. Standards concerning medical devices and drug quality have been accorded top priority by the Gujarat government in the wake of surprise audits in the country from regulatory authorities of the regulated markets. To upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities globally and in India, Gujarat government have signed eight such strategic partnerships with overseas and Indian companies in the past.

An MoU with Gujarat FDCA has been inked as part of strategic partnership which will usher in knowledge sharing on microbiological testing technologies for the pharmaceutical sector. The partnership will offer knowledge, services, and products to up-grade microbiological technology which includes media preparation, quality testing for media, growth promotion testing, environmental monitoring, active and passive air sampling, sterility testing of raw material, and end product testing for filterable and non-filterable products. Meanwhile, Abbott India which has also trained 162 drug inspectors on auditing a medical device manufacturing facility is about to offer training on new medical device rules 2017. The training is significant as the maximum number of licensed medical device units under Central Licensing Approval Authority (CLAA) scheme are in Gujarat.