Indian Pharma: How To Be Prepared To Address Unannounced US FDA Audit

In order to effectively address the unannounced review 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 specialists look for in a pharmaceutical product and API facility and how to be equipped to avoid last minute rush.

It managed topics like what are the landmines which can cause disaster, Data Integrity and role of Data Integrity in different functions, current FDA expectations, current trends of FDA-483, warning letters, India-China versus global trends, FDA review preparation for sterile finished formulation, main driver appraisal, how to ensure a robust quality control (QC) system, why QC has turned out to be favourite of FDA, grey areas in QC which requires consideration and is automation in QC an answer.

In the interim, Gujarat Food and Drug Control Administration (FDCA) and US Food and Drug Administration (FDA) have also teamed up for training the drug control authorities in Gujarat on par with the US FDA inspectors to review pharmaceutical facilities.

Gujarat has altogether 170 US FDA approved pharmaceutical units. The joint effort is a part of the global harmonization programme towards capacity building, training, networking, knowledge sharing, and consistency.

This turns out to be 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 stated, “The seminar which is held for the first time in Gujarat will immensely help drug authorities in understanding regulatory requirements of US FDA and help in better oversight of pharmaceutical industry.”

Around 100 Gujarat FDCA examiners have also been trained through online courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) as a team with US-based Underwriters Laboratories (UL).

These courses are according to the training imparted to US FDA inspectors which are of massive help to the drug controllers conducting the inspection on the shop floor of a drug facility.


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