Author: Dr. Chitra Lele, Sciformix Corporation
Achieving Operational Excellence in Drug Safety with an Effective Quality Management System
With drug safety evolving into a key priority area for the biopharmaceutical industry, the emphasis on quality and compliance has increased substantially. Regulatory agencies have made it clear that quality is integral to drug safety,
and pharmacovigilance (PV) quality systems constitute the foundation of PV operations.
The International Conference on Harmonization (ICH), European Medicines Agency (EMA) and US Food and Drug administration (US FDA) have laid out their expectations with respect to quality management systems (QMS) for PV. The past few years have also seen a steep rise in outsourcing of safety operations, (case processing, call center, aggregate report writing, signal evaluation amongst others etc.) and this has put the spotlight on how sponsor organizations provide oversight to outsourced operations with the ultimate goal of ensuring high quality and compliance of the deliverables.
This paper will review the QMS-related requirements and specifications, and will compare and contrast requirements by various organizations, primarily to elaborate on how these requirements can be implemented, what constitutes a robust QMS and how it can be built into PV operations. Means of ensuring quality and compliance through appropriate oversight will be discussed.