【摘要】：物料是藥品的物質(zhì)基礎(chǔ)。GMP有五大要素“人、機(jī)、料、法、環(huán)”中,“料”處于中心位置,所謂防止混淆、差錯、污染、交叉污染,所圍繞的對象均是“料”。因此,物料管理在GMP中處于非常重要的位置。物料管理涉及生產(chǎn)和質(zhì)量的各個部門,涵蓋供應(yīng)商審計、采購、接收、檢驗、放行、貯存、發(fā)放和使用等諸多環(huán)節(jié),重點在于控制源頭,管好流向,防止非預(yù)期使用,保證可追溯性。物料因放行狀態(tài)、復(fù)驗期、有效期、貯存條件、生產(chǎn)條件等因素的影響,使其無論處于動態(tài)還是靜態(tài),其質(zhì)量狀態(tài)都可能發(fā)生變化,物料能否采購或入庫與供應(yīng)商的資質(zhì)有關(guān),在管理上有一定的復(fù)雜性。而且,物料種類多,數(shù)量大,頻繁的出入庫操作,容易出現(xiàn)差錯,也有比較多的重復(fù)性勞動。無論是原料、輔料還是包裝材料,管理的總體流程是基本一致的,且有質(zhì)量狀態(tài)隨時間等因索而動態(tài)變化的特點,又需要實時地在線控制和信息查詢,因此非常適合采用計算機(jī)進(jìn)行管理。 本論文針對傳統(tǒng)的物料管理,結(jié)合新版GMP的相關(guān)要求,梳理出適用的物料管理流程,提出了計算機(jī)化管理的方案,結(jié)合公司的實際情況,開發(fā)出一個“物料管理系統(tǒng)”來輔助制藥企業(yè)實施對物料的GMP管理。該物料管理系統(tǒng)采用Microsoft Access開發(fā),利用公司內(nèi)部的局域網(wǎng),將數(shù)據(jù)文件儲存于服務(wù)器,程序文件安裝于終端電腦。本系統(tǒng)包含權(quán)限管理、供應(yīng)商評估、采購訂單、生產(chǎn)計劃、物料收發(fā)、放行管理等多個模塊,實現(xiàn)了物料從源頭到領(lǐng)悟的全過程控制,達(dá)到提高效率,降低差錯和對接新版GMP要求的目標(biāo)。
[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.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：F416.72;TP311.52

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 黃海波;吳登儀;臧恒昌;;制藥企業(yè)供應(yīng)商計算機(jī)輔助管理系統(tǒng)的設(shè)計[J];齊魯藥事;2012年11期

，

本文編號：2194939