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Chandrachur Datta, Partner, Vector Consulting Group analyses the hidden costs of increasing unresolved deviations during production and how this operational fragility erodes regulatory trust, ultimately impacting profitability. In a free wheeling conversation with Viveka Roychowdhury, Datta also outlines some solutions that reduced error generation, speeded up incident investigation and the possible path ahead

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To begin, could you explain why your organisation put together are report titled, From errors to excellence: A GMP-aligned approach to reducing incidents? And why is this discussion around USFDA-regulated manufacturing plants and incident management important?

In USFDA-regulated pharma plants, every deviation or unexpected event during manufacturing must be documented in the Batch Manufacturing Record (BMR). These incidents may include variations in machine speed, deviations in temperature or humidity, or any operational error. Once an incident is logged, it cannot be ignored. The root cause must be identified, and corrective and preventive actions (CAPA) must be determined before the batch can be released.

The challenge is that the number of such incidents is high across many plants, which delays batch release. These delays affect inventory, working capital, supply reliability, and sometimes force companies to expedite production or increase changeovers. Our study focused on understanding why these incidents occur so frequently and how to reduce them, improving supply chain stability and plant performance.

If this problem has been known for some time, why has it persisted? Pharma companies usually cite operator attrition and training gaps at the shop-floor level. Why hasn't the issue been resolved already?

You're right — the industry often attributes these incidents to operator mistakes, attrition, or insufficient training. As a result, the typical response has been to either train operators more or add additional checks and layers of supervision.