HACCP as a risk management tool for ensuring biosamples quality

The importance of the appropriate sample management in regulated bioanalyses is undeniable for clinical and non-clinical study support due to the fact that if samples are compromised at any stage prior to the analysis, the study results may be affected. Therefore, one of the necessary elements of clinical trials (CT) planning following the concept of quality-by-design is the conduct of risk assessment using specific tools, such as risk assessment methods. The purpose of this paper is to analyze the most general concepts of risk assessment and to select the most optimal method for quality management of CT data. The methodological basis of the study is WHO regulation and research papers on risk management. A comparative analysis of the main risk assessment methods has been conducted. Our preference is given to the hazard analysis and critical control points (HACCP) method, a systematic preventive method for CT data quality assurance. The results of the comparison have identified the advantages and disadvantages of the most popular methods of risk assessment and the opportunities of using HACCP systems for quality assurance. Unlike most risk assessment methods, the HACCP methodology uses proactive measures instead of corrective actions, so it is appropriate to use at the clinical trial site.