Enhancing Pharmacovigilance Systems through Quality Assurance Frameworks: An Integrated Approach to Drug Safety

Abstract

The continuous evolution of global drug safety regulations has necessitated the strengthening of pharmacovigilance (PV) systems through structured quality assurance (QA) frameworks. Quality assurance ensures that PV activities are consistent, accurate, and compliant with regulatory requirements, thereby reducing the risk of undetected adverse drug reactions (ADRs) and improving patient safety. This paper presents an integrated approach to enhancing PV systems through robust QA mechanisms, emphasizing process optimization, data integrity, risk-based audits, and the incorporation of digital technologies. By aligning QA processes with pharmacovigilance objectives, stakeholders can ensure the reliability of safety data and promote regulatory confidence. The discussion includes international standards such as ICH E2E, Good Pharmacovigilance Practices (GVP), and highlights the role of organizational culture in sustaining a quality-driven PV system.

Keywords:Pharmacovigilance, Quality Assurance, Drug Safety, Risk-Based Audits, Good Pharmacovigilance Practices (GVP), Regulatory Compliance, Adverse Drug Reactions, ICH Guidelines, CAPA, Data Integrity