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Following detailed evaluation of the various industry and regulatory considerations related to proposed pharmaceutical quality metrics, the ISPE Pilot Program metric set was developed to include 14 measures reflecting a mixof leading and lagging indicators collected by site and product. Twelve (12) ofthe metrics collect quantitative data responses and two (2) of the metrics (for Process Capability and Quality Culture) collect qualitative data responses using a survey based format.根据对关于建议的药品质量量度指标的各种行业和法规因素的详细评估，ISPE试点项目设定了质量量度指标，这些质量量度指标已发展至14个，它们反应了有关生产商和产品的先行指标和滞后指标。其中12个质量量度指标需要收集的是定量数据，2个质量量度指标（工艺能力和质量文化）需要收集的是定性数据，定性数据的收集主要采用调查的方式。 As the public discussion of quality metrics continues, the importance ofhow a given metric definition is established (both the numerator and thedenominator) is being increasingly recognized. Early experience from Wave 1 ofthe ISPE Pilot Program is providing the following insights:随着公众对质量量度指标的持续热议，如何规定质量量度数据（分子和分母）的重要性已经越来越备受关注。从首轮ISPE试点项目得到的早期经验为我们提供了以下几个需要考虑的问题： Standardizing metrics and definitions across companiesand sites is feasible, but challenging. 将生产企业的质量量度指标标准化可行，但是有一定的挑战性。?Definitions and termi in particular,denominators can have a big impact on a company’s ability to report on themetric with either ease or difficulty.定义和术语必须精确。特别是分母，对企业上报质量量度数据的能力有很大的影响。Frequency of data collection (e.g. quarterly, annually) analytic and reporting burden is proportional to the numberof data points collected. 数据收集的频率（例如：每季度、每年）有重大的影响；分析和报告负担与收集的数据点数成正比。Site-level metrics are more easily systematized forcollection. 生产现场级的质量量度数据更容易进行系统化收集。?Product-level metrics are significantly more c typically requiring a company to pull data from multiple systemsand can rapidly result in large data management requirements.产品级的质量量度数据收集更为复杂，通常需要企业从多个系统中抓取数据，这样就会迅速造成对海量数据的管理要求。
Next Steps 后续计划 The ISPE Pilot team is targeted to conclude the data collection period forWave 1 on 30 November, 2014. This will enable the team to analyze the data andprepare reports for participating companies, as well as publishing an overallreport for the benefit of industry and regulators in 1Q 2015.ISPE试点团队的目的是对日首轮试点项目的数据采集阶段进行总结。因为这样能使ISPE试点团队为参与试点项目的企业分析数据，准备报告，并在2015年第一季度为行业和监管部门发布综合报告。 ISPE and FDA are also working together to organize a jointly chairedworkshop, targeted for April 2015, to discuss industry learnings from the PilotProgram as well as other ongoing efforts related to quality metrics.ISPE和FDA还将于2015年4月联合举办一场研讨会，讨论试点项目中可以借鉴学习的内容，并探讨如何持续推动质量量度指标的发展。 In parallel, the ISPE team also is working to develop a Wave 2 for thePilot Program in order to:同时，ISPE还将为为第二轮试点项目做准备，目的是： Expand the number of participants. 扩大参与企业的数量?Assess a potentially adjusted set of metrics based onlearnings from Wave 1 and input from sub-teams working on Leading QualityIndicators / Quality Culture and Process Capability. 对首轮试点项目的质量量度指标进行评估，对从事收集先行质量指标/质量文化和工艺能力指标的子团队所输入的内容进行评估。Increase focus on current vs retrospective datacollection and analysis. 增加对现有和回顾性数据采集和分析的关注?Provide a forum to encourage cooperation across industrygroups in order to drive the dialogue and understanding on the use ofpharmaceutical quality metrics. 提供一个平台，鼓励形成合作的产业群，推动有关药品质量量度指标运用的对话和理解。 Quality Metrics Industry Pilot质量量度指标 Metrics details以下是质量量度指标的介绍： 1. Lot acceptance rate 批次合格率 Lot acceptance rate = Total lots released for shipping out of the total finally dispositioned lots for commercial use in the period批次合格率=在规定阶段，被最终投入生产的用于商业用途的总批次数中所有放行销售的批次所占的比例。 Definition 定义Total lots dispositioned = total number of lots for commercial use produced and/or packaged on site that went through final disposition during the period, i.e. were released for shipping or rejected (for destruction). Rejections should be counted as final disposition regardless at what production stage the rejection occurred. Release is only final release for shipping. Excludes lots that have been sent for rework or put on hold/quarantined in this period and hence are not finally dispositioned. Excludes lots that are not produced or packaged on site, but just released for CMOs.最终投入生产的批次总数=被最终投入现场生产和/或包装的用于商业用途的的总批次数，这些批次中包括放行销售的批次和不合格批次（不合格批次将销毁）。在产品开始投入生产后的任何阶段出现的不合格批次都应统计在最终投入生产的批次中。放行的批次指的是最终放行销售的批次。最终投入生产的批次总数不包括重新加工或暂存/待验的批次数，因为这些批次不能计算在最终投入生产的批次总数中。最终投入生产的批次总数中不包括在非生产现场生产或包装的，但仅放行给代工生产商的批次数。 Total lots rejected = total full lots were rejected for quality reasons. Rejected means intended for destruction or experimental use, not for rework or commercial use. Rejections should be counted regardless at what production stage the rejection occurred不合格批次总数=因质量原因而导致不合格的总批次数。不合格的批次应被销毁或作为实验用，而不能被重新加工或用于商业用途。在任何生产阶段，如出现不合格品，都应对不合格品计数。 Total lots released (“accepted”) = total lots dispositioned less total lots rejected合格的（接受的）批次总数=最终投入生产的批次总数减去不合格批次总数。 2. Total complaints rate 总投诉率 Total complaints rate = Total complaints received in the reporting period, related to the quality of products manufactured in the site, normalized by the number of packs released总投诉率=在报告期间，所有接收到的有关现场所生产的产品质量的投诉，投诉的总数根据放行数的变化而变化。 Definition 定义Packs released = Total number of packs (final product form that leaves the plant, one level less than tertiary packs, most usually it is secondary packaging unit e.g. pack of blisters or bottle in carton pack) released in the period放行数=在规定阶段，放行的总数（指的是离厂的最终产品形式，不多于三级包装，通常采用的是二级包装，例如，透明塑料罩或纸板箱中的药瓶）。 Total complaints = All complaints received in the reporting period, related to the quality of products manufactured in the site, regardless whether subsequently confirmed or not. All complaints received by the site should be counted, even if a complaint affects more than 1 site, or if eventually the root cause analysis attributes the issue to another site. Complaints related to lack of effect should be counted as well.总投诉数=在报告期间接收的所有有关现场所生产的产品质量的投诉总数，。有关药效不明显的投诉也应统计在总投诉数中。 3. Critical complaints rate 关键投诉率 Critical complaints rate = All critical complaints, normalized by the number of packs released关键投诉率=所有关键投诉的总数，根据放行数的变化而变化。 Definition 定义Critical complaints = Complaints which may indicate a potential failure to meet product specifications, may impact product safety and could lead to regulatory actions, up to and including product recalls. Critical (or expedited) complaints are identified upon intake, whether subsequently confirmed or not, based on the description provided by the complainant, and include, but may not be limited to:关键投诉=指可能预示无法满足产品质量规范的，影响产品安全性的，并可能导致承担法律责任的，甚至造成产品召回的投诉。关键（需迅速处理的）投诉的识别取决于投诉内容，是否最终作为关键投诉，应至少根据投诉人的描述以及以下内容来判断： I. Information concerning any incident that causes the drug product or its labelling to be mistaken for, or applied to, another article.产品标识错误，或标签被误用混淆。II. Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application.在已销售产品中出现细菌污染、任何重大的化学/物理/其他变更或变质，或已销售的一个或多个产品批次不符合规定的产品质量标准，无法确保用药安全。 4. Confirmed OOS rate 确认的OOS发生率 Confirmed OOS rate = Total confirmed OOS (test results that fall outside the specifications or acceptance criteria), out of all lots dispositioned by the lab during the period确认的OOS发生率=在规定阶段中，所有确认的有OOS的批次数在所有经实验室处理批次数中的比例（OOS结果指的是超出质量标准或接受标准的检验结果）。 Definition 定义Total lots tested/dispositioned by the lab = total number of lots used for commercial production that are tested and dispositioned out of the lab in the period, i.e., have a QC pass or fail decision on them. Includes: 经实验室检验/处理的总批次数=在规定阶段中，经实验室检验和处置（例如：QC决定这些批次是否合格）的用于商业生产的总批次数，这些批次：Lots for release testing (counted as 1 lot, even if sampled separately for chemical and microbiological testing, or for in-process analytical testing in lab or on shop floor) 包括用于放行检验的批次（无论对一个批次中的样品进行理化、微生物或是中间分析检验，这些从样品只能算做为一个批次）。Lots of incoming materials for analytical testing (count 1 per each analytically tested raw material and/or packaging material lot). Includes water used as raw material. 包括用于分析检验的进料批次（每一个用于分析检验的原辅料和/或包材批次都作为一个批次），包括制药用水。Lots for stability testing in that period (counted as 1 per each time point and condition sampled per the approved stability protocol) 包括在指定阶段内用于稳定性检验的批次（根据已批准的稳定性方案，在一个批次中，每个取样时间点和取样条件所取样品都作为一个批次）。Does not include environmental monitoring samples 不包括环境监控样品。Confirmed OOS = all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, formulary or applied by the manufacturer when there is not an ‘official’ monograph 确定的OOS=在没有官方药典时，超出或不符合生产商规定或使用的药品应用程序、药品主文件（DMFs)、正式文件中的质量标准或接受标准的所有检验结果。 5. Stability failure 稳定性失效 Stability failure = Total confirmed OOS related to stability testing稳定性失效=和稳定性检验相关的所有已确认的OOS。 Definition 定义Subset of the “Confirmed OOS rate” – based on stability lots tested and confirmed OOS related to stability only已确认OOS率的子集--仅以稳定性检验批次和稳定性相关的确认的OOS为基础。 6. Invalidated (unconfirmed) OOS rate 未证实的（未确认的）OOS率 Invalidated (unconfirmed) OOS rate = Total unconfirmed OOS, out of all lots tested during the period未证实的（未确认的）OOS率=在规定阶段中，所有未确认的OOS数在所有检验批次数中所占的比例。 Definition 定义Unconfirmed OOS = all OOS minus confirmed OOS (see the definition of confirmed OOS)未确认的OOS=所有OOS减去确认的OOS（参见“确认的OOS”的定义）。 7. Recall rate 召回率 Definition 定义Recall events = all US market recall events 召回事件=所有美国市场的召回事件By class = all US market recall events, class I and II 召回等级=所有美国市场的召回事件分为等级1和等级2Recalled lots = Include lots recalled either voluntarily or by regulatory order (recall implies physical removal of product from field, not just a field action or correction). Include US market recalls only 召回批次=包括主动召回和责令召回的批次（召回意味着将产品从市场上进行物理清除，而不仅仅是一次市场行动或纠正行为），召回批次只包括在美国市场上召回的批次。 8. Right first time (rework/reprocessing) 一次正确率（重新加工/返工)RFT (rework/ reprocessing rate) = Total lots that have not been through rework or reprocessing out of the total finally released lots for commercial use in the period一次正确率（重新加工/返工率）=在规定阶段，未进行重新加工或返工的批次在最终放行销售的总批次数中所占的比例。 DefinitionTotal lots released (“accepted”) = total lots dispositioned less total lots rejected (see the definition of Lot Acceptance Rate) 放行的批次总数（接受）=最终投入生产的总批次数减去不合格的总批次数（请参见批次合格率的定义）。Total lots reworked or reprocessed = all lots that have gone through rework (using alternative process) or reprocessing (using again the original process) before that final disposition in order to meet requirements for release. Only count rework or reprocessing necessitated by quality issues (for example contract manufacturing sites should exclude rework due to customer order changes). If a lot was sent for rework and received a new lot number, it should still be counted as undergone rework when finally dispositioned. 重新加工或返工的总批次数=在最终投入生产前，为符合放行要求，重新加工（使用了新的工艺）或返工（再次使用原有工艺）的总批次数，在统计该数值时，只考虑因质量问题而必须执行的重新加工或返工（例如：由于客户订单的变更而进行的重新加工不统计在该数值中）。如果一个批次进行了重新加工，并且该批次有了新的批次号，那么在该批次最终投入生产时，其仍应被统计到重新返工的批次数值中。
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【捷通资讯】FDA公布医疗器械质量量度测量指南的必要性
作者:&医捷通医疗器械咨询服务&
医疗器械－全文略读：Thereby, metrics and successful quality practices should be brought together to ensure quality enhancing measures in the pat...
Quality Metrics - Required for Medical Devices too?
质量量度---也需要？
Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading &Case for Quality& (CfQ), the FDA would like to improve the quality of medical devices. After having conducted together with the industry a detailed analysis of quality metrics with regard to medical devices, the FDA started 2011 CfQ. At that time, one of the outcomes of the analysis pointed out that companies with a company-wide quality organisation received fewer complaints - both internal and external - and had fewer quality costs compared to their business rivals.
最近，FDA公布了一个关于质量量度测量的指南。对于，FDA现在想要采用类似的方式。在题为“质量案例”（CfQ）的文中，FDA想要改善的质量。在与行业对进行了详细的质量量度分析后，FDA开始了2011质量案例。在那时，分析结果之一指出具有全公司范围的质量组织的公司收到的投诉更少，包括内部和外部的，相比于其业务竞争对手，耗费的质量成本更少。
Since 2011 the deficiencies observed by the FDA during inspections have been remaining constant year after year. The&Warning Letters statistics&show the same outcome. This is the reason why the FDA now wants to take a different path within the framework of CfQ in order to take quality enhancing measures regarding medical devices. To achieve this goal, the FDA plans 3 measures:
自2011年以来，FDA在检查中发现的缺陷保持数年稳定。警告信统计数据显示出相同的结果。这就是为什么FDA现在想要在CfQ的框架中采取不同的手段来提升的质量。为达到此目标，FDA计划采取3项措施：
1. Focus on quality - concerning this point, there are parallels to medicinal products. (Quality) metrics - relevant for medical devices - should be identified. In the medium term, these values should be used as rationales in the context of frequency of inspection. One can see here parallels to the&Quality Metrics Initiative for medicinal products.
关注质量----关于此点，有一些需要识别的与相关的质量量度类似物。在中期，这些值应被用来确定检查频次的合理性。读者可以参阅“质量量度倡议”。
2. Involvement of stakeholders: Informative and meaningful feedback should be achieved through a close collaboration between the industry, hospitals, patients, etc.&
干系人参与：通过生产行业、医院、患者等之间的紧密协作，获得具有参考意义的反馈。
3. Data transparency: quality relevant data - like e.g. recalls and inspection outcomes which may be published - should also be released in an evaluable way.
数据透明度：质量相关数据---如可以公布召回和检查结果---也应以可评估的方式进行公布。
These analyses should enable the industry to concentrate on the areas which have the strongest influence on product quality and thus on product safety. Thereby, metrics and successful quality practices should be brought together to ensure quality enhancing measures in the patients' interest.
这些分析可以促进生产行业集中精力在其对产品质量具有强大影响的领域，从而保证药品安全。因此，可度量的成功的质量规范应结合起来确保质量改进措施，保证患者利益。
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本指南的目的是帮助企业执行 质量系统和风险管理方法,以满足管理当局对 CGMP 规范的要求。管理当局同时也看到了要 将 CGMP 与其它非美国制药业的法规系统和 FDA ......? ? 负责成品生产 必须获得美国规定的产品许可: - 注册(FDA 2891表格) - 列名登记(FDA 2892表格) - 510(k)或PMA - 美国代理商 必须符合质量体系要求 - ......美国FDA 医疗器械体系法规 QSR820 中文版 Part 820——质量体系法规——目录 ...服务 820.250 统计技术 Subpart A——通用要求 Sec.820.1 范围 (a) 适用......FDA质量体系规范_四年级数学_数学_小学教育_教育专区 暂无评价|0人阅读|0次下载|举报文档 FDA质量体系规范_四年级数学_数学_小学教育_教育专区。FDA质量体系规范......美国FDA原料药生产质量管理规范( 中英文)_药学_医药卫生_专业资料。DIRECTION OF...本文件旨在为在合适的质量管理体系下制造活性药用成分 (以下称原料药) 提供有关......FDA2004年9月颁布质量管理体系规范(非执行文件)_电力/水利_工程科技_专业资料。FDA2004 年 9 月颁布质量管理体系规范(非执行文件) 月颁布质量管理体系规范( FDA20......美国FDA《 医疗器械良好制造规范 (GMP)/质 量体系 (QS )规章》 美国 FDA 现行的良好制造规范 (Good Manufacturing Practices, GMP)在质量体系 (Quality System,......介绍药品行业广泛借助质量量度来监测质量控制体系和工艺,推动药品生产的持续改进。FDA 也可 利用这些量度:制定合规及检查政策和规范,例如基于风险的药品生产商检查......加强事中监管,促进药品产业的供给侧改善——FDA质量量度计划的启示--《中国食品药品监管》2016年04期
加强事中监管,促进药品产业的供给侧改善——FDA质量量度计划的启示
【摘要】：正近年来随着GMP的逐步实施和完善,药品生产企业整体的质量管理水平得到了很大的改善。但是目前GMP认证的评级只有合格和不合格之分,对于那些检查合格的企业缺少高效的生产过程中持续监控和促进优化改进。针对这种情况需要监管理念方面的创新,提供一个企业作为第一责任人和监管部门一起进行可持续改进和监控的措施。以企业生产运行情
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【分类号】：F203【正文快照】：
近年来随着GMP的逐步实施和完善,药品生产企业整体的质量管理水平得到了很大的改善。但是目前GMP认证的评级只有合格和不合格之分,对于那些检查合格的企业缺少高效的生产过程中持续监控和促进优化改进。针对这种情况需要监管理念方面的创新,提供一个企业作为第一责任人和监管
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