Risk assessment on drug production safety based on Grey-Analytic Network Process

To strengthen the correlation analysis on risk factors of drug production safety and reduce the influence due to fuzzy judgments, a safety risk assessment method based on Grey-Analytic Network Process (G-ANP) is proposed.

First, an index system evaluating drug production safety risk is constructed according to the “Good Manufacture Practice of Medical Products,” next the influence weight of each risk index is derived by using the Analytic Network Process, then the grey number of each risk index is determined by further utilizing the grey statistical theory, and finally the risk level of drug production is obtained.

An empirical study is conducted and the results support the feasibility and practicability to use G-ANP method for drug production safety risk evaluation. The results of the case show that it is feasible and practical to use G-ANP method for drug production safety risk evaluation.

The innovation lies in the use of G-ANP method to fully consider the interdependence and interaction between the risk factors of drug production safety, which improves the objectivity in judging the risk level of drug production and provides a scientific basis for pharmaceutical manufacturers to formulate further decisions and management in the case of insufficient quantification of risk factors. Based on the findings, more targeted suggestions are made to reduce the production risk of pharmaceutical enterprises.