ABSTRACT
This chapter looks at how process management can be used not only to increase product knowledge but also to reduce risk to the quality and safety of the pharmaceutical by reducing variation. The chapter discusses some of the key issues facing pharmaceutical manufacturing today. These issues are particularly challenging for a multinational company wishing to market its products globally. The limited FDA resources were to be used to address the most significant patient risks, which were identified primarily as relating to the manufacturing process. These risks would be identified using Quality Risk Management (QRM). ICH Q9 was adopted by the USA and Japan in 2006 and within the EU in 2008. It is a detailed introduction to QRM and offers a generic framework which companies can adopt and adapt, together with examples of where QRM can be used across the product lifecycle. The development of appropriate control strategies, appropriately applied, should be the outcome of the risk management process.
