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Successful quality organisation in pharma must do more than demonstrate compliance: Subhrangshu Chaudhury
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Yash Ved, Mumbai
October 15 , 2026
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The future of pharmaceutical quality is no more paperwork. It is better science, earlier risk detection, stronger cross-functional ownership and faster learning. Quality becomes truly valuable when it protects the patient, strengthens supply reliability and helps the organisation perform correctly every day, not merely when an inspection is approaching, stated Subhrangshu Chaudhury, Cluster quality head – non-sterile formulations, Alembic Pharmaceuticals.
Chaudhury added, "Quality becomes truly valuable when it protects the patient, strengthens supply reliability and helps the organization perform correctly every day, not merely when an inspection is approaching."
"For many years, pharmaceutical quality was largely viewed through the lens of compliance: procedures, documentation, investigations and inspection readiness. These remain essential, but the quality front is changing rapidly. Successful Quality must prevent failures, enable reliable supply and build confidence in every batch reaching the patient. The first important shift is from reactive quality to predictive quality," added Chaudhury.
Chaudhury further stated that deviations, out of-specification results, complaints and recurring equipment failures should not be treated as independent events. When data from these systems are connected and meaningfully trended, warning signals can be identified before they develop into major failures. The real value of a quality metric is not the number presented in a management meeting, but the decision and preventive action it triggers.
"A second shift is from departmental ownership to shared ownership. Quality cannot be delivered by QA alone. Manufacturing must own process consistency, engineering must ensure equipment reliability, laboratories must generate scientifically sound data, and supply-chain teams must consider quality risks while making business commitments. QA should provide independent oversight while enabling functions to make the right decisions”, added Chaudhury.
Chaudhury further added, “A practical example is batch-release management. When release delays are reviewed only at month-end, problems have already accumulated. A short daily review involving QA, QC, production and planning can identify pending tests, documentation gaps and investigation dependencies early. This simple governance model can improve release timelines without compromising review depth. It demonstrates that compliance and operational efficiency need not be competing priorities.”
Digitalization and artificial intelligence will increasingly support document review, trend detection, annual product-quality review and investigation analysis. However, technology must strengthen scientific judgement, not replace it, stated Chaudhury.
Data governance, validated systems, transparent algorithms and human oversight will remain critical. A weak process does not become robust merely because it has been digitalized.
“Most importantly, the industry must move from a culture of “who made the mistake?” to “what allowed the failure?” Employees should feel confident reporting abnormalities, near misses and procedural difficulties. Management response to bad news ultimately determines the strength of the quality culture,” added Chaudhury.
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