冻干粉针剂灯检工序质量管控要点分析  

Quality Control Points in Light Inspection Process of Lyophilized Powder for Injection

作　　者：金江明 JIN Jiangming(Hangzhou Zhongmei Huadong Pharmaceutical Co.,Ltd.,Hangzhou,Zhejiang,China 310011)

机构地区：[1]杭州中美华东制药有限公司,浙江杭州310011

出　　处：《中国药业》2025年第7期12-15,共4页China Pharmaceuticals

摘　　要：目的 提升冻干粉针剂灯检工序的质量管控水平。方法 对冻干粉针剂灯检工序流程中人、机、料、法、环、测6个方面的管控要求进行总结和分析。结果与结论 通过对冻干粉针剂灯检工序进行规范化管控,可有效控制人为差错,提高灯检人员快速识别和准确剔除不合格品的能力,保障产品上市质量。Objective To improve the quality control level of the light inspection process of Lyophilized Powder for Injection.Methods The control requirements for six aspects(man,machine,material,method,environment,and measurement)of the light inspection process of Lyophilized Powder for Injection were summarized and analyzed.Results and Conclusion Specific standardized control requirements for the light inspection process of Lyophilized Powder for Injection can effectively control human errors,improve the ability of light inspection personnel to quickly identify and accurately remove non-conforming products,and ensure the quality of marketed products.

关 键 词：冻干粉针剂 灯检工序 质量管控 

分 类 号：R95[医药卫生—药学]