Risked Based Approach Commissioning and Qualification for organizations
Thursday, June 06, 2024
BioProcess Theater
BioProcess Theater
This presentation outlines risk and science-based approaches to Quality Control (CQ) within the pharmaceutical industry, aimed at optimizing efficiency, streamlining processes, and ensuring regulatory compliance. By integrating Quality Risk Management (QRM) into the Commissioning and Qualification (C&Q) processes, manufacturers can proactively identify and mitigate risks through comprehensive system risk assessments and control strategies embedded within system design and verification testing. This method advocates for the incorporation of Good Engineering Practices, fostering flexibility and agility in project execution while minimizing the need for extensive oversight and approval from Quality Assurance (QA) throughout the project lifecycle. Consequently, it facilitates reduced repeat verification testing, leading to expedited project turnaround times and heightened operational efficiency.