New Delhi, Nov 5 (PTI) High backlogs of manufacturing incidents and delays in closing investigations are affecting batch release timelines and consuming significant leadership bandwidth at pharmaceutical plants in India, according to a white paper by a consulting firm.
The white paper, The Compliance Spiral in Pharma Manufacturing by Vector Consulting Group, which is based on a survey of multiple mid- to large-scale, USFDA-approved formulation plants in India, found that every plant surveyed had incidents awaiting closure, with some investigations taking up to six months to resolve.
About 80 per cent of respondents said open investigations directly delayed batch releases, while senior leaders reported spending as much as 27 per cent of their time managing investigation backlogs, it said.
The findings assume significance as India seeks to expand its pharmaceutical industry towards a projected USD 130 billion by 2030, with manufacturers facing the need to increase output while maintaining regulatory compliance and ensuring timely release of batches.
The study suggested that recurring manufacturing incidents should not be viewed only as individual failures, but also in the context of how production work is documented, supervised and investigated.
Human errors accounted for 56 per cent of reported production incidents, while operators made an average of 120 entries in batch production records per shift, according to the survey.
The supervisory burden was also highlighted, with 80 per cent of respondents saying supervisors oversee five or more production lines during a shift, potentially limiting the time available for verification and early identification of problems.
“The real test of a robust quality system is not how much documentation it generates, but whether it helps prevent errors and resolve deviations without disrupting production,” Chandrachur Datta, partner and co-author of the white paper at Vector Consulting Group, said.
He said manufacturers needed to look beyond individual incidents to understand why they recur, noting that adding more checks may not address the root cause when underlying work processes are difficult to execute or verify.
The study also pointed to delays in the investigation process itself.
Around 83 per cent of respondents reported multiple revisions to investigation drafts, while 77 per cent linked delayed evidence capture to information gaps.
Further, 73 per cent of respondents said differences in functional priorities contributed to delays or rework in closing investigations, it said.
The white paper identified two areas for intervention — reducing the number of new incidents entering the system and accelerating closure of existing investigations.
According to the study, the proposed interventions could potentially reduce new incident generation by 30-50 per cent and shorten closure timelines for existing incidents by 20-40 per cent.
The report said capturing evidence closer to the time of an incident and addressing the causes of recurring deviations could help pharmaceutical manufacturers shift from reactive compliance management towards proactive quality management.
“Reducing incidents and investigation backlogs is an important step towards building the manufacturing capability needed to support India’s pharmaceutical growth ambitions,” the report said.
Vector Consulting Group is a homegrown management consulting firm that works across operations, supply chain, sales, new product development and project management, among other areas. PTI PLB NB
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