Last Updated on November 19, 2024 by The Health Master
Revised Schedule M
Revised Schedule M: The pharmaceutical industry is under increasing pressure to ensure product quality and safety while navigating complex regulatory landscapes. A recent industry event delved deep into these critical issues.
QRM: A Cornerstone of Pharmaceutical Excellence
FOPE and Pharma State Academy recently hosted the third installment of their PULSE series, this time focusing on Quality Risk Management (QRM).
The session, held on August 11, 2024, drew a large crowd of industry professionals eager to learn about the implications of the Revised Schedule M.
Dr. Swati Sinha from Pharma State Academy set the stage by highlighting the paramount importance of QRM in safeguarding patient health.
The session delved into the specifics of the Revised Schedule M, providing practical guidance for implementing effective risk management strategies.
Experts Weigh In
Manmohan Taneja, the State Drugs Controller and Licensing Authority for Food and Drugs Administration (FDA), Haryana, delivered a keynote address emphasizing the industry’s responsibility to prioritize patient safety through robust QRM practices.
He underscored the critical role of regulators and industry leaders in maintaining the highest quality standards for pharmaceutical products.
Dr. Udaykumar Rakibe, Founder of PharmaMantra, brought the discussion to a practical level by sharing real-world examples of QRM implementation.
He emphasized the use of Failure Mode and Effects Analysis (FMEA) as a powerful tool for identifying and mitigating manufacturing risks.
Regular maintenance, visual inspections, and effective risk communication were also highlighted as essential components of a comprehensive QRM program.
Panel Discussion
A panel of industry experts, including Dr. Bhaskaran J, Dr. Rajiv Desai, Mala Sivaramakrishnan, and moderated by Harish Jain, engaged in a lively discussion on various aspects of QRM.
Topics ranged from contamination control strategies and risk assessment tools to preventing human error through improved system competency.
Dr. Sanjit Singh Lamba stressed the importance of a proactive approach to QRM, emphasizing the role of early detection in preventing substandard products from reaching patients.
The panel also clarified the differences between ICH Q9 and the Revised Schedule M, underscoring the need for meticulous documentation.
Q&A and Future Outlook
The session concluded with a Q&A session where participants raised concerns about contamination control, change management, and global regulatory compliance.
Arjun Kapoor delivered closing remarks and expressed gratitude to all attendees.
Looking ahead, FOPE and Pharma State Academy announced the next PULSE session, scheduled for September 8, 2024, which will focus on “Qualification and Validation.”
By emphasizing the importance of QRM and providing practical insights into implementing the Revised Schedule M, this event has positioned itself as a valuable resource for the pharmaceutical industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Key Notes on Revised Schedule M: Must read
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CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
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Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
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Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
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