论文部分内容阅读
验证是指证明在药品生产和检验中任何原辅料、配制工艺、房屋设施及设备、质量控制方法等能否确实达到预期目的的有关文件证明的一系列活动。国家药品监督管理局2000年颁布的“《医疗机构制剂许可证》验收标准”第58条提出“应对制剂室设施及设备、制剂处方、工艺、质控方法的有效性进行验证”。由于设施及设备的管理是医院制剂质量管理的弱点和难点,因此对其有效性作了如下工作。
Validation refers to a series of activities that prove that any raw materials, preparation techniques, housing facilities and equipment, quality control methods, etc. in the production and testing of pharmaceuticals can really achieve the expected purpose and that the relevant documents prove. Article 58 of the “Acceptance Criteria for Permit for Preparation of Medical Institutions” promulgated by the State Drug Administration in 2000 promulgated the “verification of the effectiveness of the preparation facilities, equipment, preparation prescription, process and quality control methods of preparation rooms”. As the management of facilities and equipment is a weakness and difficulty in the quality management of hospital preparations, the following work has been done on its effectiveness.