摘要:
目的 介绍近4年济南战区被抽验制剂质量存在的问题,为促进医疗机构制剂质量提高提供参考。 方法 描述性统计2007年~2011年制剂抽样检验的各项目结果,对其存在的主要质量问题进行分析。 结果 统计抽验医疗机构制剂共1177批。不合格制剂共45批,涉及剂型15种;不合格项目56项,不合格原因有6类,以微生物限度不合格最常见(占总数的39.29%),其次为含量测定(占16.07%)、装量(占14.29%)等。 结论 针对不合格原因,医疗机构应进一步优化工艺和流程,严格遵守药品生产管理规范,提高制剂的质量标准,确保人民群众和官兵用药安全有效。
Abstract:
Objective To analyse the quality issues of preparation in Jinan Military Region and improve the quality of preparation in medical institutions. Methods According to the 2007~2011 inspection records and the test results, the main quality problems of the preparation of medical institutions was summarized and analyzed. Results A total of 1 177 batches of preparation were inspected, among which 45 batches were unqualified, involving 15 kinds of formulations. Among the 56 unqualified projects, unqualified in Microbe Restriction Test was the most (39.29%)of the total, followed by unqualified in Assay (16.07%) and Loading Capacity (14.29%) with 6 kinds of unqualified reasons. Conclusions Aiming at the unqualified reasons, the medical institutions should further optimize the technology and processes and strict compliance with Good Manufacturing Practice to improve the quality standards of preparation and guarantee that the safe and effective medication of the masses and the officers and soldiers.
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