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制药企业物料控制计算机辅助管理程序设计与应用

发布时间:2018-08-21 07:11  文章来源:笔耕文化传播
【摘要】:物料是药品的物质基础。GMP有五大要素“人、机、料、法、环”中,“料”处于中心位置,所谓防止混淆、差错、污染、交叉污染,所围绕的对象均是“料”。因此,物料管理在GMP中处于非常重要的位置。物料管理涉及生产和质量的各个部门,涵盖供应商审计、采购、接收、检验、放行、贮存、发放和使用等诸多环节,重点在于控制源头,管好流向,防止非预期使用,保证可追溯性。物料因放行状态、复验期、有效期、贮存条件、生产条件等因素的影响,使其无论处于动态还是静态,其质量状态都可能发生变化,物料能否采购或入库与供应商的资质有关,在管理上有一定的复杂性。而且,物料种类多,数量大,频繁的出入库操作,容易出现差错,也有比较多的重复性劳动。无论是原料、辅料还是包装材料,管理的总体流程是基本一致的,且有质量状态随时间等因索而动态变化的特点,又需要实时地在线控制和信息查询,因此非常适合采用计算机进行管理。 本论文针对传统的物料管理,结合新版GMP的相关要求,梳理出适用的物料管理流程,提出了计算机化管理的方案,结合公司的实际情况,开发出一个“物料管理系统”来辅助制药企业实施对物料的GMP管理。该物料管理系统采用Microsoft Access开发,利用公司内部的局域网,将数据文件储存于服务器,程序文件安装于终端电脑。本系统包含权限管理、供应商评估、采购订单、生产计划、物料收发、放行管理等多个模块,实现了物料从源头到领悟的全过程控制,达到提高效率,降低差错和对接新版GMP要求的目标。
[Abstract]:Material is the material base of medicine .GMP has five main factors: "person, machine, material, method, ring", "material" is in the central position, so called to prevent confusion, error, pollution, cross pollution, the object around is "material". Therefore, material management is very important in GMP. Material management involves various departments of production and quality, including supplier audit, procurement, receipt, inspection, release, storage, distribution and use, and so on. The emphasis is on controlling the source, managing the flow direction, and preventing unexpected use. Guarantee traceability. Due to the influence of release status, re-inspection period, period of validity, storage conditions, production conditions, etc., the quality state of materials may change whether they are in dynamic or static state. Whether the materials can be purchased or stored is related to the qualifications of suppliers. There is some complexity in management. Moreover, there are many kinds of materials, large quantity, frequent operations in and out of storage, easy to make mistakes, and a lot of repetitive work. Whether it is raw materials, accessories or packaging materials, the overall process of management is basically the same, and it has the characteristics of dynamic change of quality status with time, and needs real-time on-line control and information query. Therefore, it is very suitable for computer management. In this paper, according to the traditional material management, combined with the new version of GMP related requirements, combing out the applicable material management process, put forward a computerized management scheme, combined with the actual situation of the company, A material management system is developed to assist pharmaceutical enterprises to implement GMP management of materials. The material management system is developed by Microsoft Access. The data file is stored in the server and the program file is installed on the terminal computer by using the local area network inside the company. The system includes several modules, such as authority management, supplier evaluation, purchase order, production plan, material receiving and sending, release management and so on. Reduce errors and docking new GMP requirements to target.
【学位授予单位】:山东大学
【学位级别】:硕士
【学位授予年份】:2013
【分类号】:F416.72;TP311.52

【参考文献】

相关期刊论文 前1条

1 黄海波;吴登仪;臧恒昌;;制药企业供应商计算机辅助管理系统的设计[J];齐鲁药事;2012年11期



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