Panel Discussion: Sterility & compliance 2026: What global regulators expect today

Panellists in this video:
+ Mr Rashmi Ranjan Patra, Technical Advisor (MODERATOR)
+ Mr Soumya Kumar Panda, Sr VP – Operations, Mankind Pharma
+ Mr Rakesh Kumar Sinha, Sr VP & Head-Drug Product Manufacturing, Biological E.
+ Mr Pradipta Kumar Swain, COO, Innoxel Lifesciences
+ Mr Nirvesh C Prajapati, Sr GM, Aspiro Pharma – Specialities (Hetero Group)
+ Mr Pavankumar R Gudi, Manager – Viral Vaccines, Serum Institute of India
+ Mr Kinshuk Roy, GM – Quality Assurance, Eugia Pharma Specialities

Key Highlights:
[1] Not just SOPs. A connected, science-led Contamination Control Strategy. Ownership must cut across functions.

[2] Weak data leads to weak sterility assurance. Digital, real-time systems are becoming essential reduce data integrity issues.

[3] Always be inspection-ready. Unannounced inspections are rising. Especially for India. Compliance must be continuous, not reactive

[4] Quality culture is visible on the floor and not just in documents. Operators, deviations, decisions, all are audited. Culture gaps now trigger observations.

[5] Technologies like isolators, RABS, automation are becoming standard. They are key to manage high-risk processes. Invest strategically in them to ensure compliance tomorrow

[6] Most contamination events trace back to people. Minimisation is key. Design, automation, and training must reduce human touchpoints.

[7] Technology can reduce risk, not eliminate it. Human behaviour still defines outcomes. The real shift is enforcing compliance to enabling the right actions by design.