A new method for risk assessment of pharmaceutical excipients

Abstract

According to the modern requirements of the European Union’s Good Manufacturing Practice for Medicinal Products, a manufacturing authorization holder should guarantee the suitability of excipients included in the finished medicine. For this purpose, a formalized, documented assessment of risks associated with safety, quality, and function for each excipient should be carried out. Though the EU-GMP guidelines give an indicative list of parameters that should be taken into consideration when assessing the excipient risks, none of the known and cited sources specifies how to perform such an assessment. The present article, therefore, describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. This method represents a combination of a quantitative risk assessment (based on the risk index method) and a qualitative risk ranking method. The risk components related to safety, quality, and function of excipients as well as parameters included in them are considered, and the score points are assigned to each excipient. The developed method was used for excipient risk assessment of some marketed finished medicines manufactured by Ukrainian pharmaceutical enterprises.