The Drug Information Association (DIA) in association with the Gujarat Food and Drug Control Administration (FDCA) has recently organised a two- day international conference at Ahmedabad, Gujarat, on Chemistry, Manufacturing and Controls (CMC) compliance for pharma and biopharma industry and regulatory officials.

The conference - Pharmaceutical Quality Forum: CMC Compliance - discussed various issues related to CMC compliances, QbD (Quality by Design), ICH guidelines and new technological developments in the field of pharma industry, informs FDCA sources. The seminar, held in the first half of August, helped its regulatory officials to enhance the knowledge of CMC compliance and manufacturing, better understanding on requirement of global regulatory compliances, said H G Koshia, commissioner, FDCA.

The rapid development and constantly changing Chemistry, Manufacturing and Controls (CMC) environment of biopharmaceutical products and their manufacturing process technologies, coupled with ongoing changes in compliance regulations, has made it imperative for companies to have an effective strategy to achieve CMC compliance.

The challenges to CMC, manufacturing and in meeting compliance requirements, supply chain management opportunities and challenges were discussed in sessions along with a panel discussion and case study analysis.

About 120 pharma professionals including around 20 regulatory officials along with academicians and industry professionals have attended the seminar chaired by commissioner, FDCA. Bruce Ross, country director - India, US FDA, Dr Chetan Majmudar, president-Technical & CQA, Claris Lifesciences Limited, Kamlesh Udani, executive director, JB Chemicals Pharma Ltd, Dr Sultan Ghani, director DIA India (ex - director, Health Canada), Carrianne Wilson from Pfizer USA, Crystal Dandy from Pfizer Canada, Albinus M D'sa, Deputy Director, US FDA India and Prof Dr Aliasgar Fakruddin, Dubai Pharmacy College, Dubai have shared their rich experience during the forum meet.