【摘要】：藥品作為特殊商品,其質(zhì)量與患者的生命息息相關(guān),隨著社會(huì)的進(jìn)步,人民群眾生活水平的逐漸提高,對(duì)藥品質(zhì)量風(fēng)險(xiǎn)的認(rèn)識(shí)也在逐步提高,在這種情況下,藥品生產(chǎn)企業(yè)的首要任務(wù)是加強(qiáng)生產(chǎn)中各方面的控制,降低風(fēng)險(xiǎn)水平,保證藥品質(zhì)量。無(wú)菌制劑中的小容量注射劑,屬于高風(fēng)險(xiǎn)劑型,生產(chǎn)過(guò)程復(fù)雜,風(fēng)險(xiǎn)控制點(diǎn)多,對(duì)硬件、軟件、濕件都有著嚴(yán)格的要求,如何做到小容量注射劑的安全、有效、穩(wěn)定、均一,杜絕藥害事件的發(fā)生,降低生產(chǎn)過(guò)程中的各種風(fēng)險(xiǎn)至可接受水平,是無(wú)菌藥品生產(chǎn)企業(yè)所面臨的一個(gè)問(wèn)題與挑戰(zhàn),也是一個(gè)值得持續(xù)不斷改進(jìn)的研究課題。 本文主要運(yùn)用一些常用的風(fēng)險(xiǎn)管理工具對(duì)小容量注射劑車(chē)間從符合2010版GMP法規(guī)改造設(shè)計(jì)到生產(chǎn)過(guò)程質(zhì)量控制進(jìn)行風(fēng)險(xiǎn)評(píng)估,對(duì)生產(chǎn)過(guò)程中存在的風(fēng)險(xiǎn)進(jìn)行識(shí)別、分析、評(píng)價(jià),對(duì)不能接受的風(fēng)險(xiǎn)采取適當(dāng)?shù)拇胧┻M(jìn)行控制,最終達(dá)到降低風(fēng)險(xiǎn),保證產(chǎn)品質(zhì)量的目的,本課題運(yùn)用的風(fēng)險(xiǎn)管理工具有魚(yú)骨圖法、失效模式效果分析法(FMEA)和危害分析關(guān)鍵控制點(diǎn)法(HACCP),對(duì)車(chē)間硬件需要改造的廠房、設(shè)備、空調(diào)凈化系統(tǒng)等方面運(yùn)用該工具進(jìn)行風(fēng)險(xiǎn)評(píng)估,確定改造方案,進(jìn)行實(shí)施,通過(guò)2010版GMP認(rèn)證。 依據(jù)我公司通過(guò)2010版GMP認(rèn)證的小容量注射劑車(chē)間為例,確定小容量注射劑生產(chǎn)過(guò)程中產(chǎn)生的可見(jiàn)異物仍然是繼續(xù)存在的風(fēng)險(xiǎn),運(yùn)用魚(yú)骨圖法找出導(dǎo)致風(fēng)險(xiǎn)產(chǎn)生的因素,進(jìn)行分析研究,找出控制措施,進(jìn)行實(shí)施,將可見(jiàn)異物風(fēng)險(xiǎn)降至最低。 通過(guò)風(fēng)險(xiǎn)管理在小容量注射劑生產(chǎn)車(chē)間符合2010版GMP改造中的應(yīng)用,使我公司小容量注射劑車(chē)間順利通過(guò)國(guó)家2010版GMP認(rèn)證,然后在通過(guò)GMP認(rèn)證車(chē)間的生產(chǎn)過(guò)程中持續(xù)應(yīng)用風(fēng)險(xiǎn)管理理念找出風(fēng)險(xiǎn)點(diǎn)進(jìn)行控制,使生產(chǎn)過(guò)程中的可見(jiàn)異物得到進(jìn)一步控制。在小容量注射劑生產(chǎn)過(guò)程中持續(xù)不斷地運(yùn)用風(fēng)險(xiǎn)管理理念及工具對(duì)生產(chǎn)過(guò)程進(jìn)行風(fēng)險(xiǎn)評(píng)估,制定風(fēng)險(xiǎn)控制措施,不斷提高生產(chǎn)效率,保證產(chǎn)品質(zhì)量。
[Abstract]:As a special commodity, the quality of drugs is closely related to the lives of patients. With the progress of society and the gradual improvement of people's living standards, the awareness of drug quality risks is also gradually improving. In this case, The primary task of pharmaceutical production enterprises is to strengthen the control of all aspects of production, reduce the level of risk, and ensure the quality of drugs. The small volume injection in aseptic preparation belongs to the high risk dosage form, the production process is complicated, the risk control point is many, has the strict request to the hardware, the software, the wet part, how to make the small volume injection safe, effective, stable, uniform, It is a problem and challenge for aseptic drug manufacturing enterprises to put an end to the occurrence of drug damage events and reduce the risks to acceptable level in the production process. It is also a research subject worthy of continuous improvement. This article mainly uses some commonly used risk management tools to carry on the risk assessment to the small capacity injection workshop from the transformation design according to the 2010 edition GMP law and regulations to the production process quality control, carries on the identification, the analysis, the appraisal to the production process risk, Take appropriate measures to control the unacceptable risk, and finally achieve the goal of reducing the risk and ensuring the quality of the product. The risk management tool used in this project is the fish bone map method. Failure Mode effect Analysis (FMEA) and Hazard Analysis critical Control Point (HACCP),) are used to evaluate the risk of workshop hardware, equipment, air conditioning purification system and so on. Through the 2010 version of GMP certification. According to the example of the small volume injection workshop certified by our company through version 2010 of GMP, it is determined that the visible foreign body produced during the production of small volume injection is still a continuing risk, and the factors leading to the risk are found by using the fish bone graph method. The risk of visible foreign bodies will be minimized by analyzing and studying, finding out the control measures and carrying out the implementation. Through the application of risk management in the transformation of 2010 GMP in the small volume injection production workshop, the small volume injection workshop of our company has been successfully certified by the national 2010 edition GMP. Then, risk management concept is continuously applied in the production process of GMP certification workshop to find out the risk points and control the visible foreign bodies in the production process. In the process of small volume injection production, risk management concepts and tools are continuously used to evaluate the risk of the production process, to formulate risk control measures, to continuously improve the production efficiency and to ensure the quality of the product.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R943

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本文編號(hào)：2381412