In order to effectively address the unannounced audit of the Indian pharma companies by the US FDA, the US-based consulting firm World Compliance Seminars (WCS) recently conducted a workshop at Ahmedabad on how to be prepared timely for US FDA inspections and develop quality culture from bottom to top management in pharma companies.

The seminar covered relevant aspects like what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid last minute rush. It dealt with topics like what are the landmines which can cause disaster, Data Integrity and role of Data Integrity in various functions, current FDA expectations, current trends of FDA- 483, warning letters, India-China versus global trends, FDA audit preparation for sterile finished formulation, root cause assessment, how to ensure a robust quality control (QC) system, why QC has become favourite of FDA, grey areas in QC which requires attention and is automation in QC an answer.

Meanwhile, Gujarat Food and Drug Control Administration (FDCA) and US Food and Drug Administration (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. The collaboration is part of the global harmonization programme towards capacity building, training, networking, knowledge sharing and compliance. This becomes more significant as Gujarat shares 28% of drug exports to developed markets, including the US.

While speaking on the sidelines of the seminar, Gujarat FDCA commissioner Dr H G Koshia who was also the chief guest of the occasion said, “The seminar which is held for the first time in Gujarat will immensely help drug officials in understanding regulatory requirements of US FDA and help in better oversight of pharmaceutical industry.”

Around 100 Gujarat FDCA inspectors have also been trained through online courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with US-based Underwriters Laboratories (UL). These courses are as per the training imparted to US FDA inspectors which are of immense help to the drug inspectors conducting inspection on the shop floor of a drug facility.