FOPE and Pharma State Academy focus on Quality Risk Management in latest PULSE session

FOPE and Pharma State Academy recently hosted, third session of their PULSE series on August 11, 2024, spotlighting “Quality Risk Management (QRM)” with a special focus on the Revised Schedule M. The session drew significant participation from across the pharmaceutical industry, underscoring the critical importance of risk management in ensuring product safety and regulatory compliance.

The session kicked off with an introduction by Dr Swati Sinha from PharmaState Academy, who emphasised the importance of the day’s discussion. The focus was on the Revised Schedule M, providing attendees with actionable insights into implementing Quality Risk Management within their organisations.

The keynote address by Manmohan Taneja, State Drugs Controller and Licensing Authority FDA, Haryana, highlighted the industry’s responsibility to prioritise patient safety through effective QRM practices. Taneja stressed the importance of rigorous testing and the role of regulators and industry leaders in maintaining the quality of pharmaceutical products.

Dr Udaykumar Rakibe, Founder of PharmaMantra, presented on the practical applications of QRM, using real-world examples to explain risk assessment, control measures, and the importance of ongoing risk communication. He also detailed the use of Failure Mode and Effects Analysis (FMEA) in managing manufacturing risks, emphasising the need for regular maintenance and visual inspections.

A panel discussion followed, featuring experts like Dr Bhaskaran J, Deputy Drugs Controller, Bengaluru; Dr Rajiv Desai, Senior Technical Advisor at the Indian Pharmaceutical Alliance (IPA); and Mala Sivaramakrishnan, Director – Head of Site Quality at CIPLA. Moderated by Harish Jain, President of FOPE, the panel covered topics such as contamination control strategies, risk assessment tools, and the prevention of human error through enhanced system competency.

Dr Sanjit Singh Lamba, Managing Partner at Trillyum, urged the proactive use of QRM to prevent potential issues. He emphasised the role of detection in ensuring that substandard products do not reach patients. The panel also discussed the differences between ICH Q9 and the Revised Schedule M, and the importance of meticulous documentation.

The session concluded with an interactive Q&A segment, where participants explored specific challenges like contamination control, change management, and global regulatory compliance. Arjun Kapoor, Additional General Secretary of FOPE, delivered the closing remarks and extended a vote of thanks.

Additionally, FOPE and Pharma State Academy announced the next PULSE session, focusing on “Qualification and Validation,” scheduled for September 8, 2024.