安博电竞-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)
聚光 发布时间:2021-09-16 聚光 来源:admin 聚光 浏览次数:
       

近日,FDA发布了2020年度缺点汇总陈述,包括包罗药品、生物成品、医疗器械等范畴共2788条缺点,并对缺点产生频率进行统计,以下:

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Cite Program Area Name援用规模

483s Issued发布的483数

Biologics生物成品

28

Bioresearch Monitoring生物研究监测

98

Devices医疗器械

422

Drugs药品

349

Foods食物

1749

Human Tissue for Transplantation用在移植的人体组织

47

Parts 1240 and 1250

9

Radiologic Health放射健康

9

Veterinary Medicine兽药

100

Sum Product Area 483s from System*总483数

2811

Actual Total in System 483s**现实483总数

2788

部门缺点翻译以下:

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Long Description

缺点描写

Frequency

频率

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***[未成立书面的]合用在质量节制单元的职责和法式[或未完全遵守]。具体来讲,***

111

There 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, ***未能完全审查[任何没法注释的差别][一个批次或其任何组分未能知足其任何尺度],不管该批是不是已放行。具体来讲,***

79

Laboratory 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未包罗成立科学公道和恰当的[规范][尺度][取样打算][测试法式],以确保[组分][药品容器][密封部件][中心产物][标签][药物制品]合适恰当的判定、含量、质量和纯度尺度。具体来讲,***

58

There 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, ***未成立书面的出产和进程节制法式,以确保药物产物具有其宣称的判定、含量、质量和纯度。具体来讲,***

46

Equipment 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, ***用在药品出产、加工、包装或保留的装备未能[恰当设计][恰当尺寸][恰当位置],以运行[合适其预期用处][合适洁净和保护]的操作。具体来讲,***

44

Equipment 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, ***装备和器具未能以恰当的距离[洁净][保护][消毒],以避免[故障][污染]改变药品的平安、判定、含量、质量或纯度。具体来讲,***

42

Appropriate 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, ***未对计较机或相干系统实行恰当的节制,以确保主出产和节制记实或其他记实的更改仅由授权人员进行。具体来讲,***

38

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***用以避免无菌药品微生物污染的法式未能[成立][书面][遵守]。具体来讲,***

31

Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***未能[遵守]既定的[规范][尺度][取样打算][测试法式][尝试室节制法式],[或在履行时记实]。具体来讲,***

31

Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***未能依照书面的法式进行[主动化] [机械] [电子] 装备的平常[校准] [查抄] [查抄]以确保准确的机能 。具体来讲,***

29

Written 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[没法注释的差别][一批或其任何组分不合适尺度]的书面查询拜访记实未能[始终]包罗结论和后续办法。具体来讲,***

28

Written 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、包装或贮存进程中,未能[制订][遵守]用在装备(包罗用具)洁净和保护的书面法式。具体来讲,***

26

Testing 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, ***用在发卖的药品的查验和放行未能在放行进步行恰当的尝试室查抄以肯定合适[终究尺度][每种活性成份的判定和含量]。具体来讲,***

22

Control 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, ***未能成立用以[监测][验证]可能致使中心物料和药物产物特征变异的工艺机能的节制法式。具体来讲,***

22

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***无菌加工区在情况前提监测系统方面存在缺点。具体来讲,***

19

Employees 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, ***员工未能接管[其所履行的特定操作][现行GMP][现行GMP所要求的书面法式]的培训。具体来讲,***

18

There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***未能成立用以评估药物产物的不变性的书面测试法式。具体来讲,***

18

Batch 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, ***[未能为每批药品出产预备]批出产和节制记实[未能包罗与每批药品出产和节制有关的完全信息]。具体来讲,***

16

The 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, ***批出产和节制记实存在缺点,由于它们不包罗[出产][加工][包装][保留]中每一个主要步调的完成记实。具体来讲,***

16

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***尝试室记实未能包罗用以确保合适既定例范和尺度的所有测试、查抄和阐发中取得的完全数据。具体来讲,, ***

15

Employees 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[出产][加工][包装][保留]的员工缺少实行其所分派本能机能所需的[教育][培训][经验]。具体来讲,***

14

The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***未能[成立][记实]阐发方式的[正确度][活络度][专属性][可反复性]。具体来讲

14

There is no quality control unit. Specifically, ***没有质量节制单元。具体来讲,***

14

The written stability testing program is not followed. Specifically, ***未遵守不变性测试的书面法式。具体来讲,***

13

Aseptic 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][装备]洁净和消毒以发生无菌前提方面存在缺点。具体来讲,***

12

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***用在避免无菌药品微生物污染的法式未能包罗对[无菌][灭菌]工艺的[充实]验证。具体来讲,***

12

Written 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[制订][遵守]书面法式以致少每一年进行评价并包罗回首[投诉][召回][退货][对每种药品进行的查询拜访]的划定。具体来讲,***

12

The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***质量节制部分缺少权利[审查出产记实,以确保没有产生毛病][周全查询拜访已产生的毛病]。具体来讲,***

11

Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***[在履行出产和进程节制时未能遵守]书面的出产和进程节制法式或[未能履行时记实]。具体来讲,***

11

Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***用在[制造][加工][包装][保留]药品的厂房未能连结杰出的维修状况。具体来讲,***

11

Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***未能[记实]与书面出产和进程节制法式的相干的误差[或不公道]。具体来讲,***

11

Reports 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[对每个原辅料最少履行一个特定的判定测试][在恰当时候距离内经由过程恰当验证供给商的测试成果肯定供给商阐发的靠得住性]的环境下,接管来自原辅料供给商的阐发陈述,而未测试每一个原辅料是不是合适所有恰当的书面尺度。具体来讲,***

11

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***未能[成立][书面][遵守]用以避免非无菌药品有害微生物的法式。具体来讲,***

10

Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***首要装备的装备日记中未能包罗[洁净][保护][利用]的书面记实。具体来讲,***

10

Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***尝试室记实是出缺陷的,由于它们未能包罗在测试进程中取得的所稀有据的完全记实。具体地说,* * *

10

Written 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[成立][遵守]描写对每批中心产物的恰当样品进行[进程节制][测试][查抄]的书面法式。具体来讲,***

10

Written 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[没法注释的差别][一个批次或其任何组分不合适尺度]的查询拜访没有书面记实。具体来讲,***

10

Drug 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, ***药品未能成立由恰当不变性数据肯定的有用期,以确保它们在利用时合适恰当的判定、含量、质量和纯度尺度。具体来讲,***

9

Each 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经由过程恰当的尝试室测试进行查验。具体来讲,***

9

Equipment 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, ***当用在药品出产、加工、包装或保留时,未能供给恰当节制[空气压力][微生物][尘埃][湿度][温度]的装备。具体来讲,***

9

Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***未能[成立][书面][遵守]描写药品的所有书面和口头投诉的处置法式。具体来讲,***

9

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***未划定每一个出产阶段完成出产的时限以确保药物产物质量。具体来讲

8

Buildings 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, ***用在出产、加工、包装或保留药品的厂房未能[连结在不受啮齿动物、鸟类、虫豸和其他虫害侵扰的洁净卫生前提]。具体地说,* * *

8

Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***对书面法式的变动未[经恰当的组织单元草拟、审核和核准][经质量节制单元审核和核准]。具体来讲,***

8

Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***药品未保留恰当的[温度][湿度][光照]前提下,使其特征、强度、质量和纯度不受影响。具体地说,* * *

8

Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***主出产和节制记实缺少[完全的出产和节制申明][取样和测试法式][尺度][非凡注释][应遵守的留意事项]。具体来讲,***

8

GMP 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[延续][以足够的频率]进行GMP 培训以确保员工对合用在他们的 CGMP 要求连结熟习。具体来讲,***

7

Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***未查抄 [计较机] [相干公式系统] [记实或数据] 的输入和输出的正确性。具体来讲,***

7

Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***缺少书面法式充实具体描写[原辅料][容器][密封部件]的[领受][辨别][贮存][处置][抽样][查验][核准][谢绝]。具体来讲,***

7

Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***未能谢绝不合适既定[尺度][规格][质量节制尺度]的药品。具体来讲,***

7

Written 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, ***洁净和保护的书面法式没有包罗[责任分派][保护和洁净时候表][对利用的方式、装备和材料进行充实具体的申明][充实具体描写需要的拆解和从头组装装备的方式,以确保恰当的洁净和保护][关在撤除或消弭之前批次标识的申明][利用前庇护洁净装备免受污染的申明][与操作有关的参数]。具体来讲,***

7

You used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***,***在药品配方中利用了非药用级成份。具体地说,***

7

The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***【履行】【监视】药品【出产】【加工】【包装】【保留】的及格人员数目不足。具体地说,* * *

6

Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***装备的【保护】【清洗】【消毒】【查抄】未作记实。具体地说,* * *

6

Investigations 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【不明缘由的差别】【批次或其任何成份不合适尺度】的查询拜访没有延长到【统一药品的其他批次】【其他可能与特定的不及格或差别有关的药品】。具体地说,* * *

6

Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***未能经由过程保存硬拷贝或备份系统来包管备份数据的[正确][完全][平安避免更改、删除或丢掉]。具体地说,* * *

6

You produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically, ***你们出产高风险药品时未能供给足够的[密闭][隔离][洁净工作面][洁净器皿][人员洁净]以避免交叉污染。具体地说,* * *

6

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