What does the term "quality risk management" refer to in the context of pharmaceutical practices?

Quality risk management in the context of pharmaceutical practices refers to a systematic approach that encompasses the assessment, control, communication, and review of risks associated with pharmaceutical quality. This process is critical since the pharmaceutical industry operates under strict regulatory requirements and is committed to ensuring the safety, efficacy, and quality of products. By proactively identifying potential risks throughout a product's lifecycle—from development to manufacturing and distribution—companies can implement measures to minimize these risks, thereby protecting public health and ensuring compliance with regulatory standards.

Effective quality risk management allows for informed decision-making, prioritization of resources, and transparent communication of risks to stakeholders. It also fosters a culture of continuous improvement and adaptability in quality assurance processes, making it an essential component of good manufacturing practices in the pharmaceutical industry.