Peer-Reviewed:
Submitted: Nov. 21, 2017. Accepted: Jan. 4, 2018.
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…
