Current Edition

Achieving Operational Excellence in Drug Safety with an Effective Quality Management System

The International Conference on Harmonisation (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. Chitra Lele, PhD – Chief Scientific Officer, Sciformix Corporation – reviews the QMS-related requirements and specifications, and compares and contrasts the requirements of various organisations, primarily to elaborate on how these requirements can be implemented, what constitutes a robust QMS and how it can be built into PV operations.