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FDA发布2020年度缺陷汇总报告(含药品、生物制品、医疗器械等领域)
作者:aoa体育app下载 2021-08-30 21:06:34 18762
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近日,FDA发布了2020年度缺陷汇总报告,包含包括药品、生物制品、医疗器械等领域共2788条缺陷,并对缺陷发生频率进行统计,如下:inkMacSystemFont, "font-size:15px;background-color:#FFFFFF;">inkMacSystemFont, "font-size:17px;text-align:justify;background-color:#FFFFFF;">Cite Program Area Name引用范围483s Issued发布的483数Biologics生物制品28Bioresearch Monitoring生物研究监测98Devices医疗器械422Drugs药品349Foods食品1749Human Tissue for Transplantation用于移植的人体组织47Parts 1240 and 12509Radiologic Health放射健康9Veterinary Medicine兽药100Sum Product Area 483s from System*总483数2811Actual Total in System 483s**实际483总数2788部分缺陷翻译如下:inkMacSystemFont, "font-size:15px;background-color:#FFFFFF;">inkMacSystemFont, "font-size:17px;text-align:justify;background-color:#FFFFFF;">Long Description缺陷描述Frequency频率The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***[未建立书面的]适用于质量控制单位的职责和程序[或未完全遵循]。具体来说,***111There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***未能彻底审查[任何无法解释的差异][一个批次或其任何组分未能满足其任何标准],无论该批是否已经放行。具体来说,***79Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***QC未包括建立科学合理和适当的[规范][标准][取样计划][测试程序],以确保[组分][药品容器][密封部件][中间产品][标签][药物成品]符合适当的鉴定、含量、质量和纯度标准。具体来说,***58There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***未建立书面的生产和过程控制程序,以确保药物产品具有其声称的鉴定、含量、质量和纯度。具体来说,***46Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, ***用于药品生产、加工、包装或保存的设备未能[适当设计][适当尺寸][适当位置],以运行[符合其预期用途][适合清洁和维护]的操作。具体来说,***44Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, ***设备和用具未能以适当的间隔[清洁][维护][消毒],以防止[故障][污染]改变药品的安全、鉴定、含量、质量或纯度。具体来说,***42Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, ***未对计算机或相关系统实施适当的控制,以确保主生产和控制记录或其他记录的更改仅由授权人员进行。具体来说,***38Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***用以防止无菌药品微生物污染的程序未能[建立][书面][遵循]。具体来说,***31Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***未能[遵循]既定的[规范][标准][取样计划][测试程序][实验室控制程序],[或在执行时记录]。具体来说,***31Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***未能按照书面的程序进行[自动化] [机械] [电子] 设备的日常[校准] [检查] [检查]以确保正确的性能 。具体来说,***29Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up. Specifically, ***对于[无法解释的差异][一批或其任何组分不符合标准]的书面调查记录未能[始终]包括结论和后续措施。具体来说,***28Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, ***在药品的制造、加工、包装或储存过程中,未能[制定][遵循]用于设备(包括器具)清洁和维护的书面程序。具体来说,***26Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. Specifically, ***用于销售的药品的检验和放行未能在放行前进行适当的实验室检查以确定符合[最终标准][每种活性成分的鉴定和含量]。具体来说,***22Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, ***未能建立用以[监测][验证]可能导致中间物料和药物产品特性变异的工艺性能的控制程序。具体来说,***22Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***无菌加工区在环境条件监测系统方面存在缺陷。具体来说,***19Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, ***员工未能接受[其所执行的特定操作][现行GMP][现行GMP所要求的书面程序]的培训。具体来说,***18There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***未能建立用以评估药物产品的稳定性的书面测试程序。具体来说,***18Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. Specifically, ***[未能为每批药品生产准备]批生产和控制记录[未能包括与每批药品生产和控制有关的完整信息]。具体来说,***16The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically, ***批生产和控制记录存在缺陷,因为它们不包括[生产][加工][包装][保存]中每个重要步骤的完成记录。具体来说,***16Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***实验室记录未能包括用以确保符合既定规范和标准的所有测试、检查和分析中获得的完整数据。具体来说,, ***15Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***从事药品[生产][加工][包装][保存]的员工缺乏履行其所分配职能所需的[教育][培训][经验]。具体来说,***14The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***未能[建立][记录]分析方法的[准确度][灵敏度][专属性][可重复性]。具体来说14There is no quality control unit. Specifically, ***没有质量控制单位。具体来说,***14The written stability testing program is not followed. Specifically, ***未遵循稳定性测试的书面程序。具体来说,***13Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***无菌加工区域在[房间][设备]清洁和消毒以产生无菌条件方面存在缺陷。具体来说,***12Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***用于防止无菌药品微生物污染的程序未能包括对[无菌][灭菌]工艺的[充分]验证。具体来说,***12Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, ***未能[制定][遵循]书面程序以至少每年进行评价并包括回顾[投诉][召回][退货][对每种药品进行的调查]的规定。具体来说,***12The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***质量控制部门缺乏权力[审查生产记录,以确保没有发生错误][全面调查已发生的错误]。具体来说,***11Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***[在执行生产和过程控制时未能遵循]书面的生产和过程控制程序或[未能执行时记录]。具体来说,***11Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***用于[制造][加工][包装][保存]药品的厂房未能保持良好的维修状态。具体来说,***11Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***未能[记录]与书面生产和过程控制程序的相关的偏差[或不合理]。具体来说,***11Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***在未[对每一个原辅料至少执行一个特定的鉴定测试][在适当时间间隔内通过适当验证供应商的测试结果确定供应商分析的可靠性]的情况下,接受来自原辅料供应商的分析报告,而未测试每个原辅料是否符合所有适当的书面标准。具体来说,***11Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***未能[建立][书面][遵循]用以防止非无菌药品有害微生物的程序。具体来说,***10Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***主要设备的设备日志中未能包括[清洁][维护][使用]的书面记录。具体来说,***10Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***实验室记录是有缺陷的,因为它们未能包括在测试过程中获得的所有数据的完整记录。具体地说,* * *10Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch. Specifically, ***未能[建立][遵循]描述对每批中间产品的适当样品进行[过程控制][测试][检查]的书面程序。具体来说,***10Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, ***对[无法解释的差异][一个批次或其任何组分不符合标准]的调查没有书面记录。具体来说,***10Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***药品未能建立由适当稳定性数据确定的有效期,以确保它们在使用时符合适当的鉴定、含量、质量和纯度标准。具体来说,***9Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***每批要求不含有害微生物的药品均未通过适当的实验室测试进行检验。具体来说,***9Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, ***当用于药品生产、加工、包装或保存时,未能提供适当控制[空气压力][微生物][灰尘][湿度][温度]的设备。具体来说,***9Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***未能[建立][书面][遵循]描述药品的所有书面和口头投诉的处理程序。具体来说,***9Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***未规定每个生产阶段完成生产的时限以确保药物产品质量。具体来说8Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***用于生产、加工、包装或保存药品的厂房未能[保持在不受啮齿动物、鸟类、昆虫和其他虫害侵扰的清洁卫生条件]。具体地说,* * *8Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***对书面程序的变更未[经适当的组织单位起草、审核和批准][经质量控制单位审核和批准]。具体来说,***8Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***药品未保存适当的[温度][湿度][光照]条件下,使其特性、强度、质量和纯度不受影响。具体地说,* * *8Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***主生产和控制记录缺乏[完整的生产和控制说明][取样和测试程序][标准][特殊注释][应遵循的注意事项]。具体来说,***8GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***未能[持续][以足够的频率]进行GMP 培训以确保员工对适用于他们的 CGMP 要求保持熟悉。具体来说,***7Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***未检查 [计算机] [相关公式系统] [记录或数据] 的输入和输出的准确性。具体来说,***7Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***缺乏书面程序充分详细描述[原辅料][容器][密封部件]的[接收][鉴别][储存][处理][抽样][检验][批准][拒绝]。具体来说,***7Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***未能拒绝不符合既定[标准][规格][质量控制标准]的药品。具体来说,***7Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation]. Specifically, ***清洁和维护的书面程序没有包括[责任分配][维护和清洁时间表][对使用的方法、设备和材料进行充分详细的说明][充分详细描述必要的拆解和重新组装设备的方法,以确保适当的清洁和维护][关于拆除或消除以前批次标识的说明][使用前保护清洁设备免受污染的说明][与操作有关的参数]。具体来说,***7You used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***,***在药品配方中使用了非药用级成分。具体地说,***7The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***【执行】【监督】药品【生产】【加工】【包装】【保存】的合格人员数量不足。具体地说,* * *6Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***设备的【维护】【清洗】【消毒】【检查】未作记录。具体地说,* * *6Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy]. Specifically, ***对【不明原因的差异】【批次或其任何成分不符合标准】的调查没有延伸到【同一药品的其他批次】【其他可能与特定的不合格或差异有关的药品】。具体地说,* * *6Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***未能通过保留硬拷贝或备份系统来保证备份数据的[准确][完整][安全避免更改、删除或丢失]。具体地说,* * *6You produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically, ***你们生产高风险药品时未能提供足够的[密闭][隔离][清洁工作面][清洁器皿][人员清洁]以防止交叉污染。具体地说,* * *6
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