FOPE and PharmaState Academy conduct session on sterile drug manufacturing under Revised Schedule M
Session 18 of the PULSE initiative focuses on regulatory compliance, operational standards, and technical readiness in sterile drug product manufacturing
The Federation of Pharma Entrepreneurs (FOPE), in collaboration with PharmaState Academy, conducted the 18th session of its ongoing PULSE (Pharma Upgradation & Learning Series for Excellence) initiative. The session focused on the manufacture of sterile drug products in line with the Revised Schedule M, bringing together key stakeholders and experts from across the pharmaceutical manufacturing ecosystem.
Dr Birendra Singh, Senior President and Global Quality Head at Mankind Pharma, delivered the keynote address as Chief Guest. Dr Singh outlined the significance of Revised Schedule M and urged industry professionals to adopt the updated regulatory framework. “Aligning with the revised standards not only ensures compliance but also boosts organisational quality benchmarks, export readiness, and global credibility,” said Dr Singh. He also offered practical advice for overcoming challenges associated with implementation.
The technical session was led by Ivy Louis, Subject Matter Expert and Founder of Vi’eNnI Training & Consulting. Louis presented an in-depth overview of sterile drug manufacturing requirements, including sanitation protocols, cleanroom classifications, gowning procedures, and aseptic process validations. She highlighted the need for media fill validations, disinfectant strategies, and the role of sporicidal agents. Her session also addressed airflow visualisation studies, media fill frequency, and the regulatory rationale behind each process step.
The event featured a panel discussion moderated by Mr. Harish K Jain, President, FOPE, and Director, Embiotic Laboratories. The panel included Vishal Sharma, Co-Founder of Vi’eNnI Training & Consulting; Dhaval Surti, Technical Lead at Nivagen Pharmaceuticals, USA; Dr Sanjit Singh Lamba of Trillyum Consulting; and Ivy Louis.
The discussion explored industry-specific technical and compliance challenges. Topics ranged from differential pressure control and container integrity testing to particulate monitoring and equipment preferences for vial washing under the Revised Schedule M. Panelists also discussed integrating Form-Fill-Seal (FFS) technologies, managing LDPE containers, and controlling humidity in Large Volume Parenterals (LVP) areas.
Additional technical insights were provided on glove print testing, personnel movement strategies, autoclave unloading within Laminar Air Flow (LAF) hoods, and the integration of Non-Viable Particle Count (NVPC) systems in Small Volume Parenteral (SVP) filling lines. The panel emphasised aligning all practices with global current Good Manufacturing Practices (cGMP) to maintain sterility assurance and ensure inspection preparedness.
The session concluded with a live Q&A where participants raised real-time issues related to sterile manufacturing. Panelists provided immediate, practical solutions to operational concerns, reinforcing the session’s relevance for industry professionals focused on compliance and quality.
Session 19 of the PULSE series, focusing on the validation of sterilisers and aseptic processes, is scheduled for April 13, 2025. The PULSE initiative continues to be supported by industry associations, with Trillyum Consulting serving as Knowledge Partner and Express Pharma as Media Partner.
For further information or to register for upcoming sessions, participants are encouraged to visit the official website of PharmaState Academy.