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July 1, 2026Open Access

Quality Risk Management in Pharmaceutical Industry

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Authors

*P*Tejas Patil *Tejas Patil*Tejas Patil *Tejas Patil**P*Tejas Patil

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Overview

Literature review discusses quality risk management principles and applications in pharmaceuticals, suggesting improvements for safety and compliance.

Key Points

  • This paper aims to explore the principles and methodologies of Quality Risk Management in the pharmaceutical industry.
  • Literature review of existing Quality Risk Management frameworks and guidelines
  • Analysis of regulatory references including the ICH guideline Q9
  • Examination of the integration of Quality Risk Management into Quality by Design and Good Manufacturing Practices.
  • Quality Risk Management is essential for ensuring patient safety and regulatory compliance.
  • Integration of QRM with Quality by Design (QbD) promotes proactive risk assessment.
  • Current methodologies align with Good Manufacturing Practices to enhance pharmaceutical quality.

Cite This Study

Patil* et al. (2026) studied this question.

synapsesocial.com/papers/6a44aedf5cd2549c8bc43f1ehttps://doi.org/10.5281/zenodo.21032607
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Also Consider

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  1. 1Quality Risk Management and Process Control2025
  2. 2Updated Review on Risk Management Strategies in Quality Assurance for the Pharmaceutical Industry2025
  3. 3QUALITY BY DESIGN AND RISK MANAGEMENT IN PHARMACEUTICAL QUALITY ASSURANCE: A REVIEW ARTICLE2026
  4. 4Recent Advances in Pharmaceutical Quality Risk Management Strategies and Tools2025
  5. 5Strategic Integration of Electronic Quality Management Systems with Quality Risk Management: Advancing Pharmaceutical Compliance and Operational Excellence2026