摘要
药物作为最基础的医疗手段,不仅能够有效地治疗和预防疾病,还直接影响使用者的健康。伴随着药品数量和产量的不断提升,保障药品的质量和安全是制药企业不可忽视的核心任务,而检验检测作为发现问题风险的一种重要手段,其效果受人员、设备、环境等多方面因素影响,对此各大药物制造企业都有义务履行自己的职责,加强药物质量检测工作。在当前科技快速发展的背景下,自动化技术、信息共享平台、实时监控系统等都为药品检验工作的开展提供了有力的支持。数据完整性贯穿于药品检验的整个流程,重视药品研发实验室信息管理系统(LIMS)建设是内在需求,更是必然趋势。基于此,本文从药品研发阶段的背景出发,探索药品检验LIMS的构建与设计内容,并就如何提升药品研发质量管理水平提出相应的建设策略,以期提供交流借鉴。
As the most basic medical means,drugs can not only effectively treat and prevent diseases,but also directly affect the health of users.With the continuous improvement of the number and output of drugs,the quality and safety of drugs are the core tasks of pharmaceutical enterprises that can not be ignored.As an important means to detect the risk of problems,the effect of inspection and detection is affected by many factors,such as personnel,equipment,environment and so on.For this,major pharmaceutical manufacturing enterprises have the obligation to perform their duties and strengthen drug quality detection.In the context of the rapid development of science and technology,automation technology,information sharing platform,real-time monitoring system and so on have provided strong support for the development of drug inspection.Data integrity runs through the whole process of drug inspection.It is an internal demand and an inevitable trend to pay attention to the construction of drug research and development laboratory information management system(LIMS).Based on this,starting from the background of drug research and development stage,this paper explores the construction and design content of drug inspection LIMS,and puts forward corresponding construction strategies on how to improve the quality management level of drug research and development,in order to provide exchange and reference.
作者
张睿
ZHANG Rui(Jiangsu Economic and Trade Vocational and Technical College,Nanjing 211100,China)
出处
《实验室检测》
2024年第1期83-87,共5页
Laboratory Testing
关键词
信息管理
药品检验
管理系统
information management
drug inspection
management system
作者简介
通信作者:张睿,实验师,主要研究方向为食品检验检测、食品药品监督管理。E-mail:452479748@qq.com
