基于质量风险管理工具失效模式与影响分析法的固体制剂共线生产风险控制研究

摘 要 目的：通过以南京某制药有限公司为例分析和评估固体制剂共线生产过程中的各种失效模式，并提出对应的风险控制措施，以提高产品的质量水平。方法: 通过质量风险管理工具失效模式与影响分析（FMEA）法得到共线生产不同环节各失效模式的质量风险等级评估表，并提出风险控制措施，对风险程度不可接受的失效模式进行控制和改进。结果: FMEA法有效地减小了固体制剂共线生产过程中的诸多风险。结论:FMEA 法是一种有效提高共线生产药品质量水平的方法，然而此法有其自身的局限性，需要结合其他风险管理工具对共线生产的整体风险进行把控，对同一等级不同特点的失效模式进行具体分析和控制，以此降低固体制剂共线生产的交叉污染、混淆和空气转移风险，提高质量管理体系效率，生产出安全有效的产品。

Risk Analysis on the Collinear Production of Solid Preparations Based on Failure Mode and Effects Analysis as the Quality Risk Management Tools

ABSTRACT Objective: To analyze and estimate the risks of failure modes in a pharmaceutical Co. Ltd. in Nanjing producing solid preparations by collinear production, and come up with measurements to improve the quality level accordingly. Methods: The quality risk level evaluation table for the failure modes in the various steps of collinear production was obtained through the failure mode and effects analysis (FMEA). The risk control measurements were put forward in order to control and improve different failure modes with various unacceptable risk levels. Results:The risks of solid preparations by collinear production were greatly reduced through FMEA. Conclusion:The FMEA method is an effective way to improve the quality level of collinear products. Meanwhile, there are limitations of FMEA, and other risk management methods should be combined to control the overall risk of drug production. Moreover, the failure modes at the same risk level with different properties should be analyzed and controlled accordingly. The above methods can improve the risk management level of a company and reduce the risks of cross-contamination, mistakes and air-transferring in order to enhance the efficiency of quality management system and produce safe and effective drugs.