Gujarat FDCA's rapid microbiological testing lab at Vadodara becomes operational

The Gujarat Food and Drug Control Administration (FDCA)'s flagship project of rapid microbiological testing lab at Vadodara has finally become operational with the testing of large volume parenterals in the first phase. Estimated to have completed at a cost of around Rs.4.5 crore, the laboratory which is housed at Food and Drug Testing Lab (FDL), Vadodara, India's largest drug testing lab, also has the distinction of being Asia's first government rapid microbiological testing lab.

The lab which has now been validated and calibrated is fully equipped to check contamination in medicines imported and exported as per global regulatory requirements. This rapid microbiological testing facility at Vadodara has the capacity to test 100 plus samples in a day and will bring turnaround time for drug testing from 14 days to just 4 hours.

The project which took four years to fructify with the support of French company BioMérieux was implemented by Gujarat Medical Services Corporation Ltd (GMSCL) in collaboration with FDCA. 

Setting up of a rapid microbiological testing lab is based on an MoU between BioMérieux and Gujarat FDCA as part of strategic partnership to usher in knowledge sharing on microbiological testing technologies for the pharmaceutical sector.

The partnership will in the long run offer knowledge, services and products to upgrade 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 has 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.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=114947&sid=1