發(fā)布時間：2018-03-30 16:58

  本文選題：藥品生產(chǎn)日常監(jiān)督　切入點：藥品生產(chǎn)企業(yè)監(jiān)管法律法規(guī)　出處：《北京中醫(yī)藥大學》2017年碩士論文

【摘要】：目的:藥品生產(chǎn)日常監(jiān)督是藥品監(jiān)管部門對藥品生產(chǎn)企業(yè)采取的一種無因的且保持一定頻次的行政監(jiān)督方式,其監(jiān)督內(nèi)容是藥品生產(chǎn)企業(yè)執(zhí)行有關藥品生產(chǎn)所有法律法規(guī)的實際情況,藥品生產(chǎn)日常監(jiān)督的開展是我國法律體系的要求,是藥品監(jiān)管部門履職的一種體現(xiàn)。在以藥品GMP為核心的龐大的藥品生產(chǎn)企業(yè)監(jiān)管法律法規(guī)體系下,藥品監(jiān)管部門需要擁有足夠的人力物力按照法律法規(guī)條款逐條進行藥品生產(chǎn)日常監(jiān)督檢查,然而,藥品監(jiān)管部門實際上人力物力有限,難以按照藥品生產(chǎn)企業(yè)監(jiān)管法律法規(guī)體系所有要求對藥品生產(chǎn)企業(yè)進行全面日常監(jiān)督檢查,因此,在有限的人力物力條件限制下,藥品監(jiān)管部門需要對藥品生產(chǎn)企業(yè)進行重點日常監(jiān)督檢查。因此,本研究要從以藥品GMP為主體的藥品生產(chǎn)企業(yè)監(jiān)管法律法規(guī)體系中篩選出關鍵條款,以此作為藥品生產(chǎn)日常監(jiān)督檢查的指標,基于篩選出的日常監(jiān)督檢查指標,構建藥品生產(chǎn)日常監(jiān)督標準化指標體系,并對指標體系賦以權重,形成北京市藥品生產(chǎn)日常監(jiān)督標準化指標參數(shù)。方法:藥品生產(chǎn)日常監(jiān)督標準化指標體系的構建來源于三部分,分別是源于藥品GMP的指標構建、源于其他法律法規(guī)的指標篩選、特殊藥品生產(chǎn)企業(yè)的日常監(jiān)督標準化指標構建。其中,源于藥品GMP的指標篩選是通過事故樹分析法構建事故樹,將事故樹的基本事件與藥品生產(chǎn)企業(yè)GMP認證檢查缺陷項目結合,由此得出日常監(jiān)督內(nèi)容;源于其他法律法規(guī)的指標篩選部分,本研究選擇了從《藥品生產(chǎn)監(jiān)督管理辦法》和《藥品注冊管理辦法》中篩選指標,從中找出屬于藥品生產(chǎn)日常監(jiān)督內(nèi)容的條款。同時,將國家局、市局下發(fā)文件的落實情況和專項任務落實情況列為藥品生產(chǎn)日常監(jiān)督內(nèi)容。由于藥品生產(chǎn)特殊情況有多種類型,本研究只列出了四種藥品生產(chǎn)特殊情況作為藥品生產(chǎn)日常監(jiān)督標準化指標,但在實際藥品生產(chǎn)日常監(jiān)督中可根據(jù)企業(yè)實際情況調(diào)整。本研究采用線性加權法確定指標權重,由于指標權重與專家打分、缺陷項目出現(xiàn)頻次、事故樹理論分析有關,因此,本研究將專家打分獲得的單個指標權重、缺陷項目頻次計算出的單個指標權重、事故樹理論分析獲得的單個指標權重進行線性組合,得出單個指標的組合權重。結果:1北京市藥品生產(chǎn)日常監(jiān)督標準化指標體系組成。構建的指標體系分為四部分,分別為合法性、生產(chǎn)運營情況、變更及風險控制情況、藥品生產(chǎn)特殊情況。合法性部分由生產(chǎn)條件合法性、注冊條件合法性、其他法律法規(guī)符合情況3個指標構成;生產(chǎn)運營情況部分由21個指標組成,分別是人員培訓情況、廠房設施設備的維護保養(yǎng)情況、原輔料的儲運質(zhì)量管理情況、供應商審計情況、成品的儲運質(zhì)量管理情況、產(chǎn)品發(fā)運與召回情況、生產(chǎn)人員的操作情況、生產(chǎn)過程中間品的管理情況、產(chǎn)成品的放行情況、設備使用情況、環(huán)境監(jiān)測及清潔情況、生產(chǎn)過程控制情況、原輔料成品的檢驗情況、取樣留樣穩(wěn)定性考察等情況、試劑對照品標準品培養(yǎng)基等管理情況、確認與驗證情況、計算機化系統(tǒng)管理以及產(chǎn)品追溯情況、生產(chǎn)記錄包裝記錄完整性情況、檢驗記錄完整性情況、質(zhì)量回顧分析情況、自檢情況;變更及風險控制情況部分由變更情況、偏差管理糾正預防措施OOS調(diào)查等情況、風險評估及控制情況、上次檢查不合格項目整改情況4個指標構成;藥品生產(chǎn)特殊情況由特殊藥品管理情況、委托生產(chǎn)情況、委托檢驗情況、異地設立中藥前處理提取及集團內(nèi)共用前處理提取車間情況4個指標構成。2指標體系權重賦值結果。利用excel,從專家打分、缺陷項目頻次、事故樹理論分析三個方面分別得出了單個指標權重,再將三者得出的結果線性組合,得出了單個指標的組合權重。結論:1北京市食品藥品監(jiān)督管理局采納了本研究成果,以此制發(fā)了紅頭文件。2針對構建的北京市藥品生產(chǎn)日常監(jiān)督標準化指標參數(shù),建議北京市藥品生產(chǎn)企業(yè)嚴格執(zhí)行構建的藥品生產(chǎn)日常監(jiān)督標準化指標參數(shù)和其他藥品生產(chǎn)企業(yè)監(jiān)管法律法規(guī),從而確保持續(xù)穩(wěn)定地生產(chǎn)出符合預定用途和注冊要求的藥品。3基于構建的北京市藥品生產(chǎn)日常監(jiān)督標準化指標參數(shù),建議藥品監(jiān)管部門強化藥品生產(chǎn)質(zhì)量日常監(jiān)管,提高日常監(jiān)督檢查的針對性和有效性,加大監(jiān)管力度,提高監(jiān)管效能,切實保證藥品質(zhì)量和藥品安全。
[Abstract]:Objective: drug production is a kind of daily supervision without reason and maintain a certain frequency of the administrative supervision and drug regulatory departments take the drug production enterprises, the content of supervision is the implementation of the actual situation of all laws and regulations concerning the production of drug production enterprises, to carry out daily supervision of drug production is our country's legal system, is a reflection of the drug regulatory departments to perform their duties. In order to drug GMP as the core of the huge drug production enterprise supervision laws and regulations system, drug regulatory authorities need to have enough manpower to pharmaceutical production and daily supervision and inspection items in accordance with the laws and regulations, however, the drug regulatory departments actually limited manpower, to conduct a comprehensive daily the supervision and inspection of pharmaceutical production enterprises in accordance with all requirements of the regulatory laws and regulations of the drug production enterprises in the system so the limited manpower conditions Under the limit, the drug regulatory authorities need to focus on the daily supervision and inspection of the pharmaceutical production enterprises. Therefore, this study selected the key terms from the drug GMP as the main body of supervision laws and regulations system in pharmaceutical production enterprises, pharmaceutical production as the daily supervision and inspection indicators, selected indicators based on the daily supervision and inspection, construction of drugs the production of daily supervision and standardization of index system, and assigned to the weight of the index system, Beijing City drug production and daily supervision standardization index form. Methods: the drug production and daily supervision and standardization of index system construction from three parts, respectively is constructed from drug GMP index, screening from other laws and regulations of the index. Construction of the daily supervision standardization index of special drug production enterprises. Among them, due to the drug GMP index screening is to construct fault tree through fault tree analysis, accident The basic event tree and drug production enterprises GMP certification inspection defects with the daily supervision; from other laws and regulations of the index selection, the choice of the drug production supervision and management measures from < > and < > in the drug registration screening index, find drug production in terms of the content from the daily supervision at the same time, the State Council issued a document of the Council, and the implementation of the special task of the implementation of production and daily supervision content for the drug. Because there are many types of special drug production situation, this study only lists four kinds of drug production as a special case of drug production and daily supervision standardization index, but can be adjusted according to the actual situation of the enterprise in the actual production of drugs in daily supervision. This research adopts linear weighting method to determine the index weight, the index weight and expert scoring, frequency of the occurrence of defective items, The theory of fault tree analysis, therefore, this study will get the weight of each index of expert scoring, the weights of individual indicators calculated by the frequency of defects in the project, the theory of fault tree analysis of single target weight obtained by linear combination, combination weights of single index. Results: 1 Beijing City Drug production daily supervision and standardization of index system. The construction of the index system is divided into four parts, respectively, the legitimacy of the production and operation situation, change and risk control, special drug production. The legitimacy of the part by the production conditions of legitimacy, legitimacy and other conditions of registration, in accordance with laws and regulations constitute 3 indicators; part of the production operation composed of 21 indicators, respectively. Is the training of personnel, facilities and equipment maintenance, storage and quality management of raw materials, suppliers audit, product storage and transportation quality management, Product delivery and recall, the operation condition of production personnel, management of the production process of intermediate goods, the release of finished products, equipment, environmental monitoring and clean production, process control, inspection of finished products of raw materials, the sample stability investigation, reagent control product standard medium such management, verification and validation, computerized system management, product traceability, production record integrity packaging records, inspection records integrity, quality review, inspection situation; change and risk control in part by the change, the deviation management corrective and preventive measures OOS investigation, risk assessment and control, constitute the last inspection unqualified rectification project of 4 indicators; special drug production by special drug management, entrusted production, commissioned the inspection The situation, set up remote extraction and group sharing treatment before treatment of traditional Chinese medicine extraction workshop 4 indexes of.2 index system weight assignment results. By using Excel, from the experts, defects in frequency, the theory of fault tree analysis of the three aspects are obtained in a single index weight, and then the three are the result of a linear combination of the the combined weight of single index. Conclusions: 1 Beijing city food and drug administration adopted the results of this study, which made the red head file.2 in Beijing City drug production and daily supervision standard parameters of construction, Beijing pharmaceutical production enterprises to strictly enforce the standard parameters index of drug production and daily supervision of construction other drugs production enterprise supervision laws and regulations, so as to ensure the continuous and stable production of intended use and in accordance with the registration requirements of the construction of the Beijing City drug drug based on.3 We should produce routine monitoring standardization index parameters, suggest that drug supervision departments strengthen routine supervision of drug production quality, improve the pertinence and effectiveness of routine supervision and inspection, intensify supervision, improve supervision efficiency, and ensure drug quality and drug safety.

【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R95

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本文編號：1686802