《医疗机构制剂管理标准》制订与解析  

Formulation and Analysis on the Standard for Management of Pharmaceutical Preparations in Medical Institutions

作　　者：江华[1] 庞宁 黄竞[1] 金鹏飞[2] 刘炜 曹国颖[2] 陆进 钟明康[6] 刘向红[7] 王建华[8] 菅凌燕[9] 王永庆[10] 钱妍[11] 赵荣生[1] 甄健存[4,12] JIANG Hua;PANG Ning;HUANG Jing;JIN Pengfei;LIU Wei;CAO Guoying;LU Jin;ZHONG Mingkang;LIU Xianghong;WANG Jianhua;JIAN Lingyan;WANG Yongqing;QIAN Yan;ZHAO Rongsheng;ZHEN Jiancun(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacy,Beijing Hospital,Beijing 100730,China;Department of Pharmacy,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Pharmaceutical Specialized Committee,Chinese Hospital Association,Beijing 100035,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 311599,China;Department of Pharmacy,Qilu Hospital of Shandong University,Jinan 250063,China;Department of Pharmacy,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;Department of Pharmacy,Shengjing Hospital of China Medical University,Shenyang 110136,China;Department of Pharmacy,Jiangsu Province Hospital,Nanjing 210029,China;Department of Pharmacy,the Second Affiliated Hospital of Chongqing Medial University,Chongqing 400010,China;Department of Pharmacy,Jishuitan Hospital,Beijing 100035,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京医院药学部,北京100730 [3]首都医科大学附属北京佑安医院药剂科,北京100069 [4]中国医院协会药事专业委员会,北京100035 [5]中日友好医院药学部,北京100029 [6]复旦大学附属华山医院药学部,上海311599 [7]山东大学齐鲁医院药剂科,济南250063 [8]新疆医科大学第一附属医院药学部,乌鲁木齐830054 [9]中国医科大学附属盛京医院药学部,沈阳110136 [10]江苏省人民医院药学部,南京210029 [11]重庆医科大学附属第二医院药学部,重庆400010 [12]北京积水潭医院药学部,北京100035

出　　处：《医药导报》2023年第11期1619-1623,共5页Herald of Medicine

摘　　要：《医疗机构制剂管理标准》规范了医疗机构制剂管理工作中的基本条件、生产过程、质量管理与持续改进等要素。该标准内容借鉴《药品生产质量管理规范》(GMP)要求,兼顾各级各类医疗机构,覆盖医疗机构制剂管理的全流程。标准由中国医院协会药事专业委员会牵头编制,编制方法及流程包括问题梳理、框架建立、初稿撰写、意见征集、专家论证审议和标准形成等。该文阐述《医疗机构制剂管理标准》制订过程,并对该标准内容进行解析,以期为医疗机构制剂管理标准化、同质化提供指导。Standard for Management of Pharmaceutical Preparations in Medical Institutions normalize the baseline condition,production process,quality management and continuous improvement during the production of pharmaceutical preparations.The content draws the requirements of good manufacturing practices(GMP)to cover the whole production and management process of pharmaceutical preparations with the consideration of medical institutions at all levels.The Chinese Hospital Association Pharmaceutical Specialized Committee is in charge of the standard establishment.The establishment course includes problem-solving,framework development,project writing,solicitation of opinions,expert approval and publication of a standard.This manuscript elaborated the standard establishment process and provided some explanation of the content to guide the standardization and homogenization of pharmaceutical preparations management.

关 键 词：医疗机构制剂管理标准 药学服务 管理标准 标准解读 

分 类 号：R95[医药卫生—药学]