实施可追溯系统,并在清洁室内安全生产药物
Marta Echávarri de Miguel1, Belén Riva de la Hoz1, Margarita Cuervas-Mons Vendrell1
1Servicio de Farmacia, Hospital Infantil Universitario Niño Jesús, Madrid, España.
概括
在药房清洁室中实施计算机化可追溯系统提高了药物制造的安全性和合规性. 该系统整合了所有准备阶段,通过安全,符合立法程序,提高了患者的安全.
科学领域:
- 制药科学 制药科学
- 医疗信息学 医疗信息学
- 质量管理质量管理.
背景情况:
- 药房服务需要强大的系统来安全准备药物.
- 目前的立法要求对药物制造进行严格控制.
- 实施可追溯性可以提高患者的安全性和监管合规性.
研究的目的:
- 详细实施可追溯性和安全药物制造系统.
- 为了提高药房服务清洁室环境中的患者安全.
- 确保遵守当前制药制造立法.
主要方法:
- 一个软件程序被用来整合所有制造阶段.
- 该系统对人员,设施,设备,材料,程序和质量控制进行了参数化.
- 实施遵循"药房服务中药物制备的良好实践指南" (GBPP) 的指导方针.
主要成果:
- 该系统包括50名用户,4个加工区和113台设备.
- 参数化了435个组件和54个包装材料.
- 建立了376个标准化工作程序和13个质量控制,对无菌和非无菌药物的风险进行分类.
结论:
- 计算机化成功建立了一个可追溯和安全的药物制造系统.
- 实施的系统在受控环境中运行.
- 该项目实现了符合当前制药制造立法.
关键词:
卡利达德 (Calidad) 是一个伟大的教师.控制的环境 控制的环境药物复合是药物复合的过程.马斯特拉尔式公式 (Formulas magistrales) 是一个主要的公式.法律法规 法律法规法律法规 法律法规这些药物是无菌的.患者安全 患者安全药房服务 药房服务质量质量质量质量质量质量质量质量.沙拉布兰卡 (Sala blanca) 是一个白色的沙拉.患者的安全性.药房服务公司无菌的药物 无菌的药物更多相关视频
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