北京市药品生产日常监督标准化指标参数构建研究

发布时间：2018-03-30 16:58

本文选题：药品生产日常监督　切入点：药品生产企业监管法律法规　出处：《北京中医药大学》2017年硕士论文

【摘要】：目的:药品生产日常监督是药品监管部门对药品生产企业采取的一种无因的且保持一定频次的行政监督方式,其监督内容是药品生产企业执行有关药品生产所有法律法规的实际情况,药品生产日常监督的开展是我国法律体系的要求,是药品监管部门履职的一种体现。在以药品GMP为核心的庞大的药品生产企业监管法律法规体系下,药品监管部门需要拥有足够的人力物力按照法律法规条款逐条进行药品生产日常监督检查,然而,药品监管部门实际上人力物力有限,难以按照药品生产企业监管法律法规体系所有要求对药品生产企业进行全面日常监督检查,因此,在有限的人力物力条件限制下,药品监管部门需要对药品生产企业进行重点日常监督检查。因此,本研究要从以药品GMP为主体的药品生产企业监管法律法规体系中筛选出关键条款,以此作为药品生产日常监督检查的指标,基于筛选出的日常监督检查指标,构建药品生产日常监督标准化指标体系,并对指标体系赋以权重,形成北京市药品生产日常监督标准化指标参数。方法:药品生产日常监督标准化指标体系的构建来源于三部分,分别是源于药品GMP的指标构建、源于其他法律法规的指标筛选、特殊药品生产企业的日常监督标准化指标构建。其中,源于药品GMP的指标筛选是通过事故树分析法构建事故树,将事故树的基本事件与药品生产企业GMP认证检查缺陷项目结合,由此得出日常监督内容;源于其他法律法规的指标筛选部分,本研究选择了从《药品生产监督管理办法》和《药品注册管理办法》中筛选指标,从中找出属于药品生产日常监督内容的条款。同时,将国家局、市局下发文件的落实情况和专项任务落实情况列为药品生产日常监督内容。由于药品生产特殊情况有多种类型,本研究只列出了四种药品生产特殊情况作为药品生产日常监督标准化指标,但在实际药品生产日常监督中可根据企业实际情况调整。本研究采用线性加权法确定指标权重,由于指标权重与专家打分、缺陷项目出现频次、事故树理论分析有关,因此,本研究将专家打分获得的单个指标权重、缺陷项目频次计算出的单个指标权重、事故树理论分析获得的单个指标权重进行线性组合,得出单个指标的组合权重。结果:1北京市药品生产日常监督标准化指标体系组成。构建的指标体系分为四部分,分别为合法性、生产运营情况、变更及风险控制情况、药品生产特殊情况。合法性部分由生产条件合法性、注册条件合法性、其他法律法规符合情况3个指标构成;生产运营情况部分由21个指标组成,分别是人员培训情况、厂房设施设备的维护保养情况、原辅料的储运质量管理情况、供应商审计情况、成品的储运质量管理情况、产品发运与召回情况、生产人员的操作情况、生产过程中间品的管理情况、产成品的放行情况、设备使用情况、环境监测及清洁情况、生产过程控制情况、原辅料成品的检验情况、取样留样稳定性考察等情况、试剂对照品标准品培养基等管理情况、确认与验证情况、计算机化系统管理以及产品追溯情况、生产记录包装记录完整性情况、检验记录完整性情况、质量回顾分析情况、自检情况;变更及风险控制情况部分由变更情况、偏差管理纠正预防措施OOS调查等情况、风险评估及控制情况、上次检查不合格项目整改情况4个指标构成;药品生产特殊情况由特殊药品管理情况、委托生产情况、委托检验情况、异地设立中药前处理提取及集团内共用前处理提取车间情况4个指标构成。2指标体系权重赋值结果。利用excel,从专家打分、缺陷项目频次、事故树理论分析三个方面分别得出了单个指标权重,再将三者得出的结果线性组合,得出了单个指标的组合权重。结论:1北京市食品药品监督管理局采纳了本研究成果,以此制发了红头文件。2针对构建的北京市药品生产日常监督标准化指标参数,建议北京市药品生产企业严格执行构建的药品生产日常监督标准化指标参数和其他药品生产企业监管法律法规,从而确保持续稳定地生产出符合预定用途和注册要求的药品。3基于构建的北京市药品生产日常监督标准化指标参数,建议药品监管部门强化药品生产质量日常监管,提高日常监督检查的针对性和有效性,加大监管力度,提高监管效能,切实保证药品质量和药品安全。
[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.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R95

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