The Role of Quality Assurance in Improving Post-Marketing Surveillance: A Pharmacovigilance Perspective on Risk Management, Safety Monitoring, and Regulatory Compliance in Pharmaceutical Practice

Abstract

In an era marked by rapid pharmaceutical innovation and the globalization of drug distribution, the importance of ensuring drug safety post-launch has become an integral aspect of public health strategy. Post-marketing surveillance (PMS), a component of pharmacovigilance, plays a crucial role in identifying, evaluating, and mitigating the risks associated with medicines once they are on the market. Although clinical trials have traditionally received the majority of the focus, the inherent limitations of pre-marketing studies necessitate the establishment of robust mechanisms for monitoring real-world drug performance. Quality assurance (QA) systems, which are often underemphasized in this context, play a pivotal role in enhancing the reliability and efficiency of PMS operations. This paper investigates the intersection between quality assurance and pharmacovigilance, highlighting how structured QA mechanisms contribute to more effective safety monitoring, regulatory compliance, signal detection, data integrity, and continuous improvements in drug safety practices. Moreover, it examines current challenges, the scope of QA integration into pharmacovigilance processes, and the future of harmonized global pharmacovigilance systems.

Keywords: Quality Assurance, Post-Marketing Pharmacovigilance, Drug Safety, Risk Management