Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution.
Chinese essential medicine; Product-specific quality risk; Chemical stability; Dissolution; Risk assessment; US recall data
Citation: Wei Xu, Garth Boehm, Qiang Zheng Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies doi:10.1016/j.apsb.2015.09.009
Received: 23 June 2015 Accepted: 17 September 2015 Available online: 17 December 2015
Copyright: © 2016 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical
Sciences. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Sincere thanks to IMS Health for providing the pharmaceutical products volume data from 2009 to 2013 on the US market. We also thank the support of PKU-Hisun QbD Lab and PKU-Siyao Sterile GMP Lab.