title: Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies.
abstract: 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.
authors.affiliation: School of Pharmaceutical Sciences, Peking University, Beijing 100871, China; Center for Pharmaceutical Information and Engineering Research, Peking University, Beijing 100871, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Xu
authors.affiliation: Center for Pharmaceutical Information and Engineering Research, Peking University, Beijing 100871, China.
authors.forename: Garth
authors.initials: G
authors.lastname: Boehm
authors.affiliation: Center for Pharmaceutical Information and Engineering Research, Peking University, Beijing 100871, China; Department of Industrial Engineering and Management, College of Engineering, Peking University, Beijing 100871, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zheng
keywords: Chemical stability; Chinese essential medicine; Dissolution; Product-specific quality risk; Risk assessment; US recall data