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目的:加强制剂配制管理是防止污染和混淆的重要工作,也是确保配制质量所必须采取的措施,方法:抓质量管理:规定产品批次的划分和批号的编制,规范配制各工序操作标准和工艺规程。抓物料管理:一切物料使用有文字规定和记录。抓设备管理:规定设备档案内容,明确设备日常专人负责。设立质量管理组织机构,确定机构人员的职责网络。规定自检周期和内容,记录自检过程。组织实施验证活动。成品发放前审核配制全过程记录。结果:采用经过批准的标准,指导配制全过程,能够有效避免或及时发现配制过程中的污染,混淆和差错事故。结论:“药品的质量是生产出来的”。
Objective: To strengthen the preparation of formulation management is to prevent pollution and confusion of the important work, but also to ensure the quality of the preparation must take measures, methods: quality management: the provisions of the product batch division and batch number preparation, standardize the preparation of the process standards and processes Procedures. Grasping material management: All materials are written and documented. Grasping equipment management: the provisions of the equipment file content, a clear equipment is responsible for daily special. Establish a quality management organization and determine the network of responsibilities of agency personnel. Provide self-test cycle and content, record self-test process. Organize verification activities. Finished product distribution before the audit of the whole process of preparation records. Results: Using approved standards to guide the preparation of the whole process, can effectively avoid or timely detection of contamination, confusion and error in the preparation process. Conclusion: “The quality of medicines is produced.”