氟康唑氯化钠注射液中可见异物分析及控制

Analysis and control of visible particles in Fluconazole and Sodium Chloride Injection

目的分析并找出氟康唑氯化钠注射液可见异物出现的影响因素,并进行控制及改进,保证产品质量。方法使用鱼骨图对生产过程中各方面的因素进行分析,总结可见异物的产生原因并逐项控制。结果通过对生产各因素的总结汇总,严加控制氟康唑氯化钠注射液的生产过程,形成了有效的可见异物控制措施。结论可见异物问题直接关系着产品质量和企业形象,应长期严格执行控制措施,使可见异物处于可控状态。

ObjectiveTo analyze the causes of visible particles in Fluconazole and Sodium Chloride Injection,formulate the controllable measures and improve,to insure the quality of production.MethodsThe fishbone diagram was used to analyze all aspects in the production process,summarize the causes of the visible particles and control.ResultsThrough the summary of each factor,keeping control strictly in Fluconazole and Sodium Chloride Injection′s production process,to form an effective visible particles control measures.ConclusionVisible particles direct affects the quality and corporate imagement,so it is necessary to perform the controllable management,to realize the controllable management of visible particles.