The lab which is now being validated and calibrated is scheduled to become operational soon to check contamination in medicines imported and exported as per global regulatory requirements.
Setting up of a rapid microbiological testing lab by Gujarat Medical Services Corporation Limited (GMSCL) is done with assistance from BioMérieux. This is followed by an MoU with Gujarat FDCA as part of strategic partnership to 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.
Of late, due to growing global regulator scrutiny, Indian pharma companies are making conscious efforts to understand what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid compliance issues in terms of manufacturing and drug quality.
French company BioMérieux is also training Gujarat FDCA inspectors to audit drug quality.
Drug regulators are also being equipped on areas of data Integrity to meet FDA expectations and how to ensure a robust quality control (QC) system. Meanwhile, Gujarat FDCA and US FDA have also collaborated for training the drug control officials in Gujarat on par with the US FDA inspectors to audit pharmaceutical facilities.
Gujarat has in total 170 US FDA approved pharmaceutical units and shares 28% of drug exports to developed markets, including the US. The collaboration is part of the global harmonization programme towards capacity building, training, networking, knowledge sharing and compliance.
Gujarat government have signed eight such strategic partnerships with overseas and Indian companies in the past to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities.
US FDA team during its visit also appreciated Gujarat FDCA efforts to curtail supply of spurious herbal drugs to the US market.
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 (MD) 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.