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.

Understanding the Adsorption and Desorption of Sitagliptin Phosphate Monohydrate on SS2343, Glass, and PTFE Using QCM-D and Raman Spectroscopy

“…The consequences of having adulterated drugs in the manufacturing process also include regulatory noncompliance business interruption and damage to corporate reputation, leading ultimately to profit losses . From 2011 to 2013, 21% of product recalls were due to cross-contamination . There were also repeated incidents that the U.S. Food and Drug Administration (FDA) attributed to the failure to adequately clean and sterilize equipment. , Crucially, insufficient cleaning was among the top 10 reasons that pharmaceutical plants failed FDA inspections.…”