Product knowledge grows and evolves during the life of a product. In order to maintain a
state of control and deliver product with consistent quality throughout its commercial life …

Background During the commercial manufacturing phase of the product lifecycle, specific
elements of the PQS are used to identify and manage PACs. Per ICH Q10, these include …

Post-approval changes are inevitable and necessary throughout the life of a drug product−
to implement new knowledge, maintain a state of control, and drive continual improvement …

Post-approval changes are inevitable and necessary throughout the life of a drug product—
to implement new knowledge, maintain a state of control, and drive continual improvement …

Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug
product. Because many PACs require prior approval by individual regulatory agencies each …

This article is the second in a series of six articles intended to provide a holistic primer on the
field of quality risk management (QRM). The first article, Quality Risk Management 101 …

ABSTRACT The purpose of Quality Risk Management is to illustrate practical ways to
analyze the risks to quality system, providing guidance along the way to achieving effective …

Summary International Conference on Harmonisation (ICH) Q9 focuses on the behaviors of
industry and the regulatory authorities on the primary principles of quality risk management …

It is becoming evident that quality risk management within regulated, life sciences
environments is a valuable component of an effective quality management system (QMS). A …

This paper investigates the concept of quality risk management (QRM) maturity as it applies
to the pharmaceutical and biopharmaceutical industries, using the results and analysis from …