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This is a Literature Review study.

Quality Risk Management and Process Control

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This review discusses challenges in quality risk management (QRM) and highlights strategies for regulatory compliance and patient safety.

Quality risk management (QRM) frameworks face implementation challenges, impacting effectiveness in the pharmaceutical industry.
Inadequate training and organizational resistance contribute to inconsistent application of quality risk management practices.
Effective integration of QRM with quality management systems can aid in addressing barriers and improving patient safety.
Proactive strategies and regular training are essential for transforming QRM from regulatory obligation to a strategic tool.

Aher et al. (2025) studied this question.

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