Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation

Abstract

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

• AHP-fuzzy comprehensive evaluation
• pharmaceutical excipients
• quantitative risk assessment
• risk assessment
• supply chain

Declarationof interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.

Supplementary material available online.

Supplementary Table S1-S15