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August 5, 2025International Journal of Research in Pharmaceutical SciencesOpen Access

An FMEA-driven holistic approach to quality risk management for new product introduction in pharmaceutical commercial plant: navigating global regulatory landscapes

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Authors

NVNikhil Arun Vyawhare

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Overview

This review demonstrates a regulatory-aligned strategy for quality risk assessments in pharmaceutical manufacturing, emphasizing FMEA's role in risk prioritization.

Key Points

  • Quality risk management is essential for ensuring safety and compliance during new product introduction in pharmaceuticals.
  • The FMEA method aids in evaluating risks through Risk Priority Numbers across various stages of product development.
  • Regulatory guidelines like ICH Q9 and WHO TRS enhance the framework for conducting effective quality risk assessments.
  • A structured FMEA template supports objective decision-making and risk evaluations among multidisciplinary teams.

Cite This Study

Nikhil Arun Vyawhare (2025) studied this question.

synapsesocial.com/papers/689522009f4f1c896c42902ahttps://doi.org/10.26452/ijrps.v16i3.4788
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  5. 5QUALITY RISK MANAGEMENT IN PHARMACEUTICAL INDUSTRY2026