FOPE, PharmaState Academy’s 16th PULSE Session held on Oral Liquids manufacturing under Revised Schedule M

The Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy successfully conducted Session 16 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, marking another milestone in the industry’s journey toward Revised Schedule M compliance. The session focused on the Manufacture of Oral Liquids.

Keynote address: Simplifying compliance for quality excellence

The session opened with a keynote address by Dr Viranchi Shah, Spokesperson – IDMA, COA Member – Pharmexcil, and Promoter & Director – Saga Lifesciences Limited. Dr. Shah emphasised the importance of quality-driven processes and the need to simplify operational systems within pharmaceutical companies to achieve seamless compliance with Revised Schedule M. He encouraged industry professionals to shift their focus from regulatory burden to proactive quality management, ensuring India’s pharmaceutical sector continues to lead on a global scale.

Expert educator session: The session’s education segment was led by Abhijit S. Kulkarni, VP CQA (Global Compliance & Biotech CQA), Lupin, who provided an in-depth, practical overview of manufacturing best practices for oral liquids. He highlighted the criticality of sanitary equipment design, advocating for smooth, easily cleanable surfaces to prevent residue accumulation and microbial contamination. Kulkarni further stressed the importance of purified water systems in oral liquid manufacturing, underscoring the need for continuous online monitoring of conductivity and TOC levels, proper sanitary design of storage vessels, and validated recirculation methods. He also addressed homogeneity challenges, detailing how proper recirculation and filtration ensure uniformity throughout manufacturing, filling, and storage.

Panel discussion: Industry leaders address practical challenges

The session’s panel discussion, moderated by Harish K Jain, President, FOPE & Director, Embiotic Laboratories, brought together renowned industry experts, including Dr Udaykumar Rakibe, Pharmaceutical Quality Expert (30+ years of experience), A.V. Jayakumar, President-Quality, Ajanta Pharma, and Abhijit S. Kulkarni, VP CQA, Lupin.

The discussion covered key aspects from the live Questions asked by the participants on the topic of oral liquid dosage form manufacturing. The experts addressed critical questions regarding storage conditions for raw materials, relative humidity for ingredients like sugar,  integration of bottle manufacturing with filling lines and more during the 90-minute-long direct Q&A with participants.

A key topic was batch-wise cleaning validation and contamination control, where panelists discussed the importance of closed-system designs, the transition from water-based bottle cleaning to air jet methods, and the role of proper differential pressure maintenance to prevent dust contamination. The panel also explored vendor qualification for secondary packaging materials and trend analysis in water testing as critical elements of maintaining high-quality oral liquid production standards.