Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. The cadence of publication steadily increased as ICH Q8, ICH Q10, and ICH Q11 emerged, as thought leaders sought to provide practical guidance to industry on the application of QRM. This article will focus on selected publications addressing general, rather than specific, applications of QRM.
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.