Development of the model for the non-conformance correction and prevention process in clinical trials

Abstract

The use of the CAPA-planning method to correct and prevent the risks emergence when organizing and conducting clinical trials (CT) of new drugs can close the cycle of actions between identifying the problem and the action to solve it. Our preliminary analysis of regulatory documentation showed the lack of unified harmonized requirements for this type of processes when organizing and conducting CT. Аim. To develop the algorithm for using the CAPA-planning method during the process of non-conformance correction and prevention when organizing and conducting CT. Materials and methods. The practical approaches used to develop CAPA-plans were assessed. The algorithm for the process of non-conformance correction and prevention was created. Methods of meta-analysis, abstraction, synthesis and generalization were used in this work. Results. Our analysis of the experience of using organizational structures for designing CAPA-plans has shown that the most convenient and effective for work is the form of drafting and execution of the CAPA-plan in the form of a consolidated table of all non-conformances identified. Quality management of CT using the CAPA-planning method is a multi-stage process that begins with non-conformance identification during the inspection or control and ends with the documented correction and prevention of all non-conformances identified. Conclusions. A review of the existing methods for organizing CAPA-plans indicates the absence of the general principles for their drafting, registration and work with them. The algorithm for the interfunctional process for non-conformance correction and prevention with the help of the CAPA-planning method has been developed.