Assessing the Efficacy of Process Analytical Technology (Pat) in Detecting Out-of-Specification (Oos) Results During Pharmaceutical Manufacturing

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Saji, Sinci
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2025-05
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In this study, it was shown that Process Analytical Technology (PAT) is an effective tool in improving product quality and reducing Out-of-Specification (OOS) results during pharmaceutical manufacturing in India. The research aimed to evaluate the adoption and challenges of PAT, with a focus on its role in detecting Out of Specification results, process deviations and monitoring Critical Quality Attributes (CQAs) in real-time. A survey of 123 experienced professionals from various sectors of the Indian pharmaceutical industry was conducted and Quantitatively analysed to assess the effectiveness, barriers, and opportunities for PAT implementation. The results revealed the PAT’s ability to detect OOS results and improve process control compared to conventional methods. PAT also helped to identify CQAs accurately, thus allowing early interventions and minimizing potential product recalls. Despite the overwhelming recognition of PAT’s benefits, several challenges were identified that impede its full adoption. These includes Technical Barriers, Resource related barriers, Regulatory Challenges as well as Organisational Barriers The study concludes that while PAT is highly regarded for its ability to enhance product quality and manufacturing efficiency by the real time monitoring of OOS results and process deviations, its widespread adoption in the Indian pharmaceutical industry is hindered by technical, financial, regulatory, and organizational challenges. To address these issues, the study recommends the implementation of regular and up to date training programs, development of cross-functional PAT teams, and stronger engagement with regulatory bodies to simplify approval processes. The findings also suggest that academic institutions should incorporate PAT into curricula to build a skilled workforce capable of supporting its integration into industry practices. These findings provide valuable insights for industry practitioners, policymakers, and educators aiming to foster more effective use of PAT in pharmaceutical manufacturing, ultimately contributing to improved operational excellence and product quality in the sector.

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