QUALITY RISK ASSESSMENT (QUALITY METRICS) IN PHARMACEUTICAL

Description

Quality Risk Assessment (QRA) is a systematic process of identifying, analyzing, and mitigating risks associated with pharmaceutical product quality. It involves evaluating potential hazards, their likelihood of occurrence, and the severity of their impact on product safety and efficacy. QRA helps ensure that products meet quality standards and regulatory requirements throughout their lifecycle, from development to post-market surveillance. It also facilitates continuous improvement by prioritizing risk mitigation efforts and optimizing resource allocation.