ABSTRACT
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of C&Q – namely impact assessments and system criticality. Have the current challenges been addressed by the update? Does the updated guidance provide clarity on the application of QRM to C&Q? This article explores how these changes bring a modern approach to C&Q.