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医院普通制剂室是药局的重要组成部分。医院自制制剂,其品种多,用途广,数量大,使用普遍。为确保自制制剂质量,我们对普通制剂室按GMP要求,着重从人员素质,生产环境,操作流程、原辅料及相应的软件方面进行了系统的整顿和治理,建立起一套比较完整,与制剂生产相适应的管理体系。经军区卫生部检查验收,达到制剂室验收标准要求。我们具体做法: 一、降低和减少不利因素,保证制剂质量稳定 1.提高人员素质,降低或减少人为差错。 《药品管理法》第十六条对人员要求作了
General hospital preparation room is an important part of the pharmacy. Hospital homemade preparations, its variety and wide use, the number of large, the use of common. In order to ensure the quality of homemade preparations, we conducted a systematic rectification and management of personnel according to GMP requirements in terms of personnel quality, production environment, operation procedures, raw materials and corresponding softwares, and established a set of more complete, Production adapted to the management system. Inspection and acceptance by the Military District Ministry of Health, to meet the acceptance requirements of the preparation room. Our specific approach: First, reduce and reduce adverse factors to ensure the stability of preparation quality 1. Improve the quality of personnel, reduce or reduce human error. Article 16 of the “Drug Administration Law” made a request to personnel