Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor

Abstract

Outsourcing is increasingly used by the vaccine manufacturers. When the manufacturing activities are outsourced, the contract manufacturer's Good Manufacturing Practice compliance needs to be confirmed through auditing. In the same way, when distribution is outsourced, the contract distributor's Good Distribution Practice compliance needs to be confirmed through auditing. The objective of this study was to develop an audit preparation tool for the pharmaceutical contract vaccine distributor and to validate its contents by using the Delphi method. Based on this, a tool was developed for the contract vaccine distributors. The Delphi method was used with a group of 14 experts from the pharmaceutical industry, authorities and university. The response rate in the Delphi questionnaire round was 100 %. The tool consisted of 33 quality items, out of which 29 (88%) achieved the pre-defined agreement rate level (>75%). The four quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert group suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good. The resultant questionnaire is ready to use. Developed the ready-to-use questionnaire based on critical factors evaluation, gives an objective picture of the possibilities of the potential partner and help organisations make quality decision on the selection of contract vaccine distributors. The contract vaccine distributor must be permanently controlled and analysed, so as to maintain the required quality and to keep low level of costs.