On September 8, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 4 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative. The session, which focused on Qualification and Validation, saw participation from over 200 attendees. It underscored the industry’s demand for learning about the Revised Schedule M and its impact on pharmaceutical manufacturing.
A high percentage of participants—85 per cent—rated the session 10/10, reflecting the relevance and quality of the content. The series is part of an ongoing effort to provide in-depth learning on compliance with regulatory guidelines.
The session began with an introduction from Dr Swati Sinha, Co-founder of PharmaState Academy. She outlined the goals of the PULSE initiative and emphasised the importance of the day’s focus on Qualification and Validation. The keynote address was delivered by Dr Hemant G Koshia, Commissioner of the Gujarat Food and Drugs Control Administration, who discussed the Revised Schedule M and its role in ensuring quality compliance. Dr Koshia emphasised the need for self-inspections and improved complaint handling to advance patient safety.
Dr Sanjit Singh Lamba, Managing Partner at Trillyum Consulting, led the session as an expert educator. With over 35 years of experience in global manufacturing and regulatory compliance, Dr Lamba provided an extensive overview of Qualification and Validation processes under Revised Schedule M. He detailed the stages of qualification—design, installation, operational, and performance—and explained the significance of process validation and the triggers for revalidation. He also discussed the Risk-Based Approach to validation and the role of Continuous Process Verification in managing changes in processes, equipment, or facilities.
An interactive panel discussion followed, featuring Dr Subhash Pande, Principal Adviser for cGMP Compliance, Vinod Kalani, Co-chairman FOPE, and Harish Jain, President of FOPE. The panel addressed practical challenges in qualification, validation processes, change control, and data integrity throughout the product lifecycle. During the Q&A, topics like process validation, cross-contamination prevention, and cleaning validation were explored. Dr Pande stressed the importance of data generation for changes in cleaning processes, while Dr Lamba clarified process validation types according to global standards.
Kalani provided practical insights into process validation, particularly its flexibility during batch size deviations and changes in manufacturing environments. The panel concluded with a discussion on environmental monitoring after facility upgrades, emphasising the importance of requalification and validation.
The session ended with closing remarks from Aprajita Takiar, Senior Vice President of FOPE, who thanked the speakers and participants.
Session 5 of the PULSE series, focusing on Water Systems & Qualification, is scheduled for September 22, 2024. The series is supported by industry associations and aims to equip professionals with practical knowledge on compliance with the Revised Schedule M.