Date: 20-Nov-2019

Gujarat FDCA in association with DIA, US FDA, EMA & EDQM rolls out series of workshops on API regulations

In order to understand how supply chain affects compliance of active pharmaceutical ingredients (API) and finished product quality, the Gujarat FDCA in association with Drug Information Association (DIA), US Food and Drug Administration (FDA), European Medicine Agency (EMA) and European Directorate for Quality of Medicine and Healthcare (EDQM) have jointly rolled out a series of workshops from November 18 to November 22, 2019 themed ‘Quality and supply chain integrity’ to help manufacturers and regulators understand the quality and regulatory requirements of APIs. Ensuring quality and integrity of APIs today requires understanding and incorporating quality risk management principles throughout the API life-cycle and raw materials. The workshop is aimed at providing updates on recent initiatives, activities and interpretations of Current Good Manufacturing Practices (cGMP) compliance and API manufacturing from US, EMA and EDQM experts in quality and compliance. Letitia Robinson, country director, India Office, US FDA, Roberto Conocchia, scientific administrator, EMA, Florence BENOIT-GUYOD, head, API inspections, EDQM, Gujarat Food and Drug Control Administration (FDCA) Dr Hemant Koshia and B Venkateswarlu, director, Drug Control Administration, Telangana are the key experts of the workshops. “With every passing day, canvass of compliance is getting bigger, broader and demanding a strong connectivity among all elements of the supply chain. Therefore, compliance is not just getting limited to the shop floor of the pharma manufacturing unit. Compliance begins from the feed stock material that initiates all the inputs used in the manufacture and ends at the point of use or point of administration of the drug or medical device,” explained Gujarat FDCA Commissioner Dr Koshia about the significance of the workshops