This is the second in a series of six articles intended to provide a holistic primer on the field of quality risk management (QRM). This installment reviews the origins of pharmaceutical risk management and regulatory thinking that led to the establishment of QRM as a unique discipline in pharmaceutical development and manufacturing.
This article marks the first of a series intended to provide a holistic primer on the field of quality risk management (QRM). The series will provide background information for those new to the QRM discipline and will explore topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.
To some extent, the Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2) has come and gone without much fanfare. Perhaps that’s because prior guidance documents surrounding risk-based quality management practices stole its thunder, and sponsors, CROs, and investigators were already well on their way to finding ways to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results,” as advocated by ICH E6 (R2).