Quality Management Systems (QMS) for Safety and Risk Management – A Regulatory Requirement Or A Business Need?

Dr. Chitra Lele Ph.D.

[This post is the first part in a series that will focus on achieving operational excellence with an effective quality management system.]

The role of pharmacovigilance or product vigilance (PV) has changed from a regulatory and legal imperative for capturing and reporting adverse events, to a business imperative for risk assessment, risk management and risk mitigation. Regulatory oversight of companies’ safety activities for approved pharmaceutical products is now much more holistic than the previous limited objective of assuring that license holders establish adequate and compliant procedures to meet their legal obligations. Regulations are targeted towards strengthening companies’ PV systems and defining clear roles and responsibilities across both the regulatory agencies and the industry.

Thus the erstwhile largely reactive system is being transformed into one that is proactive, robust and more clinically useful for benefit-risk assessment of the product at the level of an individual. The volume and complexity of drug safety data that is captured, processed, analyzed and reported has grown substantially. These developments have resulted in an acute need for companies to optimize their PV systems and processes. They have led many companies to outsource safety operations to specialized providers who have the required scientific expertise as well as operational excellence to provide effective and cost-optimized solutions in a globally distributed model.

Operational complexity increases with the inclusion of multiple groups and hand-offs. Being able to adapt fast with respect to proactive patient safety and regulatory compliance necessitates efficiency and scalability in operations and consistency in quality.

With increased emphasis on quality and compliance, regulatory agencies have also made it clear that quality is integral to product safety and PV quality systems constitute the foundation of PV operations. The Quality Management System (QMS) is essential to, and needs to drive, the biopharmaceutical PV operations. It is not a mere obligation or a mandate. It needs to be a living system that determines the way the PV system works in the company and needs to lay down the framework that guides compliance and quality of the PV system.

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