FOPE and PharmaState Academy complete second PULSE session on pharmaceutical quality systems

The Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy announced the successful completion of the second session of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, held on July 28, 2024. The session focused on the critical topic of Pharmaceutical Quality Systems, lasted over three hours, and included extensive discussions and a Q&A session. The event was attended by over 900 participants with more than 2000 views on various social media platforms.

The session commenced with an introduction by Dr Swati Sinha, co-founder of PharmaState Academy, who set the tone for the day by highlighting the importance of continuous learning and upgradation in the pharmaceutical sector. Following this, Sanjay Gupta, General Secretary of FOPE, delivered the welcome address, underscoring FOPE’s commitment to supporting and advancing the industry.

Further, Dr Umesh S, Additional Drugs Controller, Karnataka, delivered a compelling keynote address. He emphasised the necessity of implementing robust quality management systems to ensure compliance with regulatory standards and maintain the highest levels of drug safety and efficacy.

The highlight of the session, according to the statement was an in-depth presentation by Dr Ranjit Barshikar, CEO of QbD/cGMP Consulting and United Nations Adviser, Geneva. Dr Barshikar provided a comprehensive overview of the Pharmaceutical Quality System, stressing the need for compliance with Good Manufacturing Practices (GMP), effective monitoring of outsourced activities, proper storage and handling of products, and regular self-inspections to maintain quality control. He also discussed the significance of investigating deviations, implementing preventive measures, and utilising tools such as fishbone diagrams, FMEA, and risk ranking for identifying potential issues.

The session continued with a panel discussion moderated by Harish Jain, National President FOPE & Director at Embiotic Laboratories, including, P Ramesh, Deputy Drugs Controller (Hq), Karnataka, Dr Vinay Nayak, Independent Director at Aarti Pharmalabs, Dr Ranjit Barshikar, CEO of QbD/cGMP Consulting and United Nations Adviser, Geneva,  Ajay Mallesha, Quality Assurance Manager, AstraZeneca, and Dr Sanjit Singh Lamba, Managing Director, Triyllum Consulting

The discussion covered the role of regulatory agencies, the challenges faced by the Indian pharma industry, and the critical quality attributes for drug development and manufacturing. Panelists emphasised the importance of skilled manpower, regular cleaning verification studies, and the application of machine learning in pharmaceutical manufacturing. They also addressed data integrity, GDPR, and the need for change control in product manufacturing.

AVPS Chakravarthi, Chairman of FOPE Telangana & A.P., concluded the session with closing remarks and also gave vote of thanks, expressing gratitude.

The PULSE series is supported by major industry associations including CIPI, LAGHU Udyog Bharti, Indian Pharma Machinery Manufactures Association, Karnataka Drugs and Pharmaceuticals Manufacturers’ Association, Himachal Drug Manufacturers Association, Rajasthan Pharmaceutical Manufacturers Association, Federation of MP Chamber of Commerce and Industry and The Pharmaceutical Manufacturers’ Association of Tamil Nadu, Drug Manufacturers’ Association.

Express Pharma served as the media partner, and Trillyum Consulting acted as the knowledge partner for the event.