目的:描述在药房服务的洁净室中实施可追溯性和安全的药物制造系统以提高患者安全性的过程,根据现行立法。
方法:该过程在2021年9月至2022年7月之间进行。该软件程序整合了“药学服务药物准备良好实践指南”(GBPP)中概述的所有推荐制造过程阶段。软件程序中对以下部分进行了参数化:人员,设施,设备,起始材料,包装材料,标准化的工作程序,和质量控制。
结果:共有50个用户,包括4个精加工区和113台设备。435个组件进行了参数化(195个原材料和240个制药专业),54种包装材料,376个标准化工作程序(其中123个对应无菌药品,253个对应非无菌药品,其中52名非无菌是危险的),此外还有17个是高风险的,327中等风险,32低风险,和13个质量控制。
结论:生产过程的计算机化允许根据现行法规在受控环境中实施可追溯性和安全的药品生产系统。
OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation.
METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the \"Good Practices Guide for Medication Preparation in Pharmacy Services\" (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls.
RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls.
CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.