Competencies for the position of the Responsible Person in good distribution practice

Abstract

Defined competencies are not currently established for technical personnel working in the pharmaceutical wholesale distribution setting who must adhere to Good Distribution Practice (GDP). Educational development for the Responsible Person (RP) position is topic-driven and not competency based. This research aimed to establish a validated tool to identify competencies relevant for the role of the Responsible Person (COMP-RP tool). There were 62 criteria based on competencies, knowledge, and skills across six domains which were included in the draft COMP-RP tool developed. The tool was based on a Likert scale ranking. Two Delphi rounds by a panel of experts were applied for validation. Data were statistically analysed and passed through cut-off points to reach final version of the COMP-RP Tool. The selection of wholesale distribution, quality and leadership skills, knowledge and competencies were consistently rated both Delphi rounds. The final validated COMP-RP Tool consisted of 58 criteria across the six domains.