本文選題：風險管理 + 凍干粉針劑�。� 參考：《延邊大學》2017年碩士論文

【摘要】：風險管理是以預防及控制風險因素為目的的科學方法,已經(jīng)在諸多領域得到了有效應用。全球各個國家正在結合自身情況,致力于不斷探索藥品管理中存在的規(guī)律,從而建立更為完善、更為有效的管理制度,以保障產品質量。實施藥品風險管理,首先要對其有一定的認識;其次,要不斷切合自身獨特的實際情況,制定出更為合理的管理制度,使藥品質量風險的影響得到最大限度地降低。首先,據(jù)國家食品藥品監(jiān)督管理總局的數(shù)據(jù)統(tǒng)計,按照1998年修訂的藥品GMP認證,認證范圍有凍干粉針的企業(yè)共有1468戶,而按照2010年修訂的藥品GMP認證中,認證范圍內有凍干粉針的企業(yè)卻有480戶。說明隨著新版GMP認證的實施,要求對凍干粉針的生產過程更為嚴格,企業(yè)不易達到標準,從而通過GMP認證。在這480戶企業(yè)中吉林省通過新版GMP認證的企業(yè)只有7戶,而延邊州卻僅僅只有一戶。本文介紹了凍干粉針劑獨有的特點。其作為新型劑型產品具有穩(wěn)定性好,可長期保存;加入對應的溶劑后能夠迅速溶解,恢復藥物特性;容易實現(xiàn)無菌操作。然而,使用有問題的凍干粉針產品后,可能產生血栓等問題,直接影響人的生命健康。因此,為了避免產品中產生可見異物,就要將風險管理應用到凍干粉針劑生產過程中,降低生產過程中失效模式的風險水平至可接受水平,從而生產出安全有效、穩(wěn)定均一的產品。所以應用質量風險管理的科學方法和技術來預防、控制、降低或消除風險,已成為凍干粉針劑生產企業(yè)面臨的重要難題。其次,本文詳細介紹了與風險管理有關的理論。從風險管理的流程出發(fā),從風險評估到風險控制,再到風險交流進行了概述。在風險管理工具中,失敗模式與影響分析(FMEA)法通過計算風險優(yōu)先系數(shù)能夠得到定性或定量的分析,更為直觀地看到風險水平的變化,因此本論文使用FMEA工具進行風險管理。最后,本文將FMEA法具體應用于A公司X凍干粉針劑的生產過程中,分析了凍干粉針劑生產過程中注射用水系統(tǒng)、空調系統(tǒng)、人流與物流、西林瓶的清洗與滅菌、膠塞與鋁蓋的處理、藥液的配制、灌裝、凍干、軋蓋、貼簽包裝等環(huán)節(jié)的潛在失效模式,在原有控制措施下進行風險評估,對不能接受的風險點使用改進措施進行控制。并使用FMEA法對凍干粉針劑生產中注射用水系統(tǒng)、空調系統(tǒng)、生產過程中人物流、配制、洗瓶、膠塞清洗、灌裝、凍干、燈檢、包裝等環(huán)節(jié)存在的高風險水平的風險點進行風險控制執(zhí)行后的風險再評估。RPN數(shù)據(jù)表明,這些改進措施有效降低了風險水平至可接受水平,從而達到保障產品質量的目的。凍干粉針劑屬于非最終滅菌的無菌制劑,必須對可能污染藥品的塵埃粒子、微生物及細菌內毒素等風險采取有效的控制措施,最大限度地降低產品的污染風險,確保所生產的藥品符合預定用途。
[Abstract]:Risk management is a scientific method aimed at preventing and controlling risk factors and has been effectively applied in many fields.Every country in the world is devoting itself to explore the law of drug management, so as to establish a more perfect and effective management system to ensure the quality of products.To implement drug risk management, we should first have a certain understanding of it; secondly, we should constantly adapt to our own unique actual situation and formulate a more reasonable management system to minimize the impact of drug quality risk.First, according to the statistics of the State Administration of Food and Drug Administration, according to the drug GMP certification revised in 1998, there are 1468 enterprises with lyophilized powder needles, and according to the revised drug GMP certification in 2010,Within the scope of certification there are freeze-dried powder needle enterprises have 480 households.It is shown that with the implementation of the new version of GMP certification, the production process of freeze-dried powder needle is more strict, and the enterprise is not easy to reach the standard, thus passing the GMP certification.Of the 480 enterprises, only 7 were certified by the new GMP in Jilin Province, while only one in Yanbian.This paper introduces the unique characteristics of lyophilized powder injection.As a new dosage form, it has good stability, can be preserved for a long time, can dissolve quickly after adding corresponding solvent, and can recover the characteristics of medicine, and it is easy to realize aseptic operation.However, the use of problematic lyophilized powder needle products may lead to problems such as thrombosis, which directly affect human life and health.Therefore, in order to avoid visible foreign bodies in the product, risk management should be applied to the production process of lyophilized powder injection, and the risk level of failure mode in the production process should be reduced to an acceptable level, so that the production is safe and effective.Stable and uniform products.Therefore, the application of scientific methods and techniques of quality risk management to prevent, control, reduce or eliminate risks has become an important problem faced by enterprises producing lyophilized powder injections.Secondly, this paper introduces the theory of risk management in detail.From the process of risk management, from risk assessment to risk control, and then to risk exchange are summarized.In the risk management tool, the failure mode and impact analysis (FMEA) method can get qualitative or quantitative analysis by calculating the risk priority coefficient, and can see the change of risk level more intuitively. Therefore, this paper uses FMEA tool to manage risk.Finally, this paper applies FMEA method to the production process of X lyophilized powder injection in company A, and analyzes the injection water system, air conditioning system, people flow and logistics, cleaning and sterilizing of Xilin bottle in the production process of freeze-dried powder injection.The potential failure modes of rubber plug and aluminum cap, preparation, filling, freeze-drying, rolling cover, labeling and packaging are evaluated under the original control measures, and the improvement measures are used to control the unacceptable risk points.The injection water system, air conditioning system, human logistics, preparation, flask washing, rubber plug cleaning, filling, freeze-drying, lamp checking in the production of lyophilized powder injection were carried out by FMEA method.The data of risk reassessment after the implementation of risk control in packaging and other links show that these improved measures can effectively reduce the risk level to acceptable level and thus achieve the purpose of ensuring product quality.The lyophilized powder injection is a non-final sterilizing sterile preparation. It is necessary to take effective measures to control the risks of dust particles, microorganisms and bacterial endotoxin that may contaminate the drug, so as to minimize the risk of contamination of the product.To ensure that the drugs produced are in accordance with the intended use.
【學位授予單位】：延邊大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R95

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