Risk Classification of Drug Manufacturing Enterprises

OBJECTIVE To construct a new model of GMP inspection based on the degree of risk.

METHODS Through literature research and seek the opinions of relevant experts engaged in drug inspection, the primary indicators of risk level evaluation of drug manufacturing enterprises were formed. The expert questionnaire survey was designed using Delphi method to consult the index system, and the weights of the constructed risk evaluation indexes were calculated using hierarchical analysis in order to obtain the risk evaluation index system for the whole life cycle of drug inspection.

RESULTS The constructed risk grading index system of drug manufacturing enterprises contained 3 primary indicators, 11 secondary indicators and 28 tertiary indicators. The primary indicators were process risk(0.5396), compliance risk(0.2970) and inherent risk(0.1634) in order of weight; the top ranked secondary indicators were complexity of production process(0.2947), product quality(0.1650) and change complexity(0.1254); the complexity index of special nature drugs(0.1138), common line index(0.1138), non-sterile drug index(0.1117) and key personnel change index(0.1045) were the tertiary indicators with higher weights.

CONCLUSION By developing a risk assessment model for drug manufacturing enterprises, it can promote the improvement of drug inspection system in the context of decentralization, make full use of limited inspection resources, reduce the frequency of inspection for low-risk drug manufacturing enterprises, and positively motivate more enterprises to strengthen risk self-discipline and effectively assume the main responsibility of being the first responsible person for drug quality and safety.