多因素评估法在药企物料分类中的应用

Applying multi-factor assessment method in material classification in pharmaceutical manufacturing

做好药品生产中的物料管理工作,首先需对物料进行准确分类,才能确保后续CAPA采取的针对性和正确性。通过文献查阅及问卷调查,了解常用分类方法不适用于GMP物料分类的原因及药企对物料分类中的风险管理运用情况。运用鱼骨图工具,识别物料管理全过程中的各个风险因素。用失效模式与影响分析工具,建立能综合所有已识别的各个风险因素的多因素评估法模型,并以实例证明该模型的优点。

Classification of materials is the first and key step to material management. Appropriate material classification system facilitates GMP compliance and Corrective and Preventive Actions（ CAPA）. Literature research shows the inadequacy of existing classification methods. Questionnaire survey reveals that risk management tools are not yet widely used among manufacturers. A risk-based multifactor material classification system is proposed and elaborated. Risk factors are identified with fishbone diagram and materials are then prioritized with Failure Mode Effects Analysis（ FMEA）. Two real cases provided evidence of the benefits of the classification system proposed.