Chapter 5 - Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System

Abstract

Validation is an important element in an overall quality management system (QMS). It helps to demonstrate the reliability and performance of processes and support systems. Validation is linked and supported by all other QMS elements, including change control, audit, corrective actions, and deviation management, which help ensure the process and systems addressed in the validation program remain in a validates state. These QMS elements should provide information as to the status and relative importance of given process steps and system aspects, essential to the proper design and evaluation of validation studies. A sound, risk based QMS can provide assurance that the parenteral process will remain in a controlled and validated state. Decisions should be made on a risk basis, ensuring that validation studies are designed to address those process steps and system aspects having the greatest impact of process performance. Likewise when properly planned and performed, validation helps to provide assurance that given QMS decisions and actions are effective. To that end, this chapter will explore the principles employed to develop and implement a risk-based QMS that can be effectively linked to and supported by modern validation approaches.