Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies, Developed by the Inter-Company IMPALA Consortium.

Clinical trial regulations recommend a dynamic and risk-based approach to the quality management strategy for a medicinal product development program. Sponsor companies are required to identify factors that are critical to quality, to perform ongoing evaluation of the changing risks and quality status in clinical trials and adapt their quality strategy accordingly. The Inter-Company Quality Analytics (IMPALA) not for profit consortium supports the shift towards dynamic quality management of clinical trials by providing publicly available data analytics packages to measure changing risks to patient safety and data reliability. The Critical to Quality Assessment Methodology is the latest initiative developed by the IMPALA consortium in support of dynamic quality assurance and risk management. This paper describes the methodology, which is an iterative process conducted throughout a clinical trial, beginning with risk factor identification and assessment, and development of the initial quality strategy based on this evaluation. It continues with the generation of quality evidence through the execution of a variety of activities, including quality assurance audits, process compliance monitoring, real-time study surveillance activities, etc., utilizing both traditional and analytical methods. From there quality conclusions are determined and documented in the Critical to Quality Assessment Report (CAR). These steps are executed on a continuous basis throughout the development of a medicinal product across all clinical trials and the CAR serves as a pivotal knowledge management tool, disclosing Good Clinical Practice compliance conclusions for stakeholders.