Objective:This study aims to establish a methodology and model for evaluating the risk index of pharmaceutical manufacturing.Methods:Various risk factors in the pharmaceutical manufacturing process were analyzed and weighted by the priority chart method across five aspects:inherent product risks,production process risks,quality control and quality assurance risks,compliance risks,complaint and recall risks,and a risk index model of pharmaceutical manufacturing was developed to calculate the pharmaceutical manufacturing risk index.Results:Different weights were assigned to the main risk factors,and a model for evaluating the pharmaceutical manufacturing risk index was successfully established.Conclusion:This model is user-friendly,easy to understand,and yields reliable results.It can serve as a reference tool for regulatory authorities when planning inspections and issuing risk warnings.
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