Experts and veterans from the pharma industry came together for a panel discussion on to discuss on ‘Importance of Impurities Profiling in Assuring GMP’
Express Pharma, in association with SCIEX and Beckman Coulter Life Sciences, recently organised an event in Ahmedabad to discuss on ‘Importance of Impurities Profiling in Assuring GMP’. More than 70 delegates took part in the event wherein experts and veterans from the pharma industry came together to examine various aspects of GMP and explore effective strategies to implement them in pharma facilities.
The event started with the welcome address by Sanjiv Das, Deputy Copy Editor, Express Pharma and Express Healthcare. This was followed by an address by Dr Anoop Kumar, Market Development Manager — Pharma, Sciex who gave insights on Solution for Qualitative and Quantitative Application’.
The next presentation was given by Dr Amitav Mohanty, Application Scientist, Beckman Coulter, who gave a lecture on ‘How healthy you cells are? Monitor using flow cytometry: A multi-parametric high-throughput tool.’
A panel discussion was held following the presentation by Dr Amitav Mohanty. Dr Jayant B Dave, VP, Indian Pharmaceutical Association, Gujarat State Branch and Partner, Apostle Remedies, Vadodara was the moderator for the session. The panelists who took part in the discussion were Jitendra Kumar Jain, AVP Quality, Amneal Pharmaceuticals; Dr Arvind Kukrety, Deputy Drugs Controller (I) Zonal Office, Ahmedabad; Dr Viranchi Shah, Chairman, Indian Drugs Manufacturers’ Association, Gujarat and Chairman, Saga Laboratories; Dr HG Koshia, Commissioner, FDCA Gujarat; Gaurang Oza, Chief mentor and CEO, Vaibhav Analytical Services; Dr Anoop Kumar, Market Development Manager — Pharma, Sciex, SG Belapure, MD, Zydus Hospira Oncology and Ramanuj Samal, Application Scientist, Beckman Coulter.
In the opening remarks, Dr Dave highlighted that impurity tests and specifications as important determinants of product quality and GMP as a tool to evolve and maintain quality specifications. He briefly dwelt on scientific and regulatory importance of the same. Jitendra Kumar Jain talked about meeting the newer challenges in elemental impurities tests in view of newer specifications in USP. Gaurang Oza discussed issues related to practical problems faced by analysts in view of very unrealistic specifications of impurities. However, Ramanuj Samal mentioned that impurities at times also become triggers for development of new drug molecules.
Dr Arvind Kukrety gave an in depth account of regulatory norms in the country based on Impurities General Chapter in IP, Drug & Cosmetic Act, Sch V, Sch Y etc. He also conveyed that any new drug as defined in Drug & Cosmetic Rules has to meet with all quality and safety requirements including General Chapters on Impurities. Dr Anoop Kumar presented a technical account of mass spectrometry hyphenated techniques for enabling quantitative estimation of impurities at reporting threshold and characterisation at identification threshold.
Dr Viranchi Shah talked about difficulties faced during dossier submission while securing product registration for exports and practical issues during manufacture to check the impurities. SG Belapure conveyed that the goal should be to establish as stringent standards as possible for impurities so that products can meet with expectations of several regulators; the specifications should be reviewed and revised from time to time based on product and process understanding.
Dr HG Koshia, giving an idea about process impurities and degradation products, gave a brief account of the mechanism evolved by FDCA Gujarat, to constantly review the quality of products in the market and bring to light Not of Standard Quality products and remove them from distribution as a public health measure.
In his concluding remarks, Dave said, “Much attention needs to be given to inner purity of one’s own self as we pay to the purity of molecules. Good science blended with ethics constitute a respected profession.”
A presentation by Ramanuj Samal on ‘Reducing the risk of product recall at reduced cost of ownership followed the panel discussion.
The event concluded with a vote of thanks by Neeraj Khurana, Head Marketing, Beckman Coulter. The delegates also got an opportunity to interact with their peers at the networking dinner that followed the event.
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