明胶空心胶囊生产原材料质量控制刍议

Brief Discussion on Quality Control for Raw Materials of Vacant Gelatin Capsules

目的阐述明胶空心胶囊生产原材料质量控制的相关要求或规定,以期进一步规范相关生产企业严把生产质量关。方法通过分析胶囊剂铬超标事件中原料质量标准和检验工作实施情况,讨论明胶质量标准、安全性能、检验能力以及药品、药用辅料生产质量管理规范对原材料的控制要求,以寻求空心胶囊原辅料和成品质量管理方法。结果明胶空心胶囊生产原材料质量的控制,需要明胶生产企业、胶囊生产厂和制药企业均要严格按照关于明胶空心胶囊生产的相关规定,切实、有效地实施检验和质量控制活动。结论应加强原材料质量控制,生产者必须严格执行检验制度,从进货源头把住质量关。

Objective To, ;be the gelatin hollow capsules prod, ）n raw material quality control related requirements, in order to further standardize the production enterprises in strict production quality. Methods It was briefly discussed on demands of quality control for gelatin capsules according to Good Manufacturing Practice for Drug, Good Manufacturing Practice for Pharmaceutical Adjuvant, relevant industry standards and the necessary equipment for its examination, by analyzed Chromium assayfor gelatin Capsules.Results The gelatin hollow capsules production quality control of raw materials, production enterprises, need gelatin capsule production plant and pharmaceutical enterprises should be strictly in accordance with the relevant provisions of the gelatin hollow capsules production, cogent, effective implementation of inspection and quality control activities.Cone I us ions It was necessary to control the source and strictly examine the quality of raw materials in accordance with the specification of vacant gelatin Capsules, to control the quality of Vacant Gelatin Capsules and its raw materials.