FDA 2014财年483缺陷排行前十 - 药群论坛

更多细节，参见2014财年483表缺陷排行“2014财年检查缺陷汇总”。

排行

Short Description

Long Description

Frequency

简述

详述

频次

Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

145

111

程序没有书面化，没有完全遵守

应用于质量控制部门的职责和程序没有【书面化】【完全遵守】。例如。。。。

145

Scientifically sound laboratory controls

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, ***

109

222

科学合理的化验室控制

化验室控制未包括科学合理的设施和适当的【质量标准】【规格】【取样计划】【检测方法】，用于保证【成分】【药品容器】【容器】【中控物料】【标识】【药品】符合适当的鉴别、剂量、质量和纯度标准。例如。。。。

109

Investigations of discrepancies, failures

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, ***

333

不符合性、失败调查

未能彻底审核【所有未能解释的不符合性】【批次不合格或其组成不符合其质量标准】，有些批次已销售。例如。。。

Absence of Written Procedures

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, ***

444

缺失书面程序

生产和工艺控制没有设计书面程序，用以保证药品应具备的鉴别、剂量、质量和纯度。例如。。。

Written procedures not established/followed

"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, *** "

555

未建立/遵守书面程序

未【建立】【遵守】用于药品生产、工艺处理、包装和存贮设备，包括工器具的清洁和维护的书面程序。例如。。。

Procedures for sterile drug products

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***

565

无菌药品的程序

未【建立】【书面化】【遵守】设计用于防止无菌药品微生物污染的程序。例如。。。

Testing and release for distribution

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, ***

676

检测和放行销售

在放行前，药品的检测和放行销售未包括适当的化验室对【最终质量标准】【每一种活性物质鉴别和剂量】的测试。例如。。。

Cleaning / Sanitizing / Maintenance

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, ***

78`7

清洁/消毒/维护

设备和工器具未按适当的周期【清洁】【维护】【消毒】，以防止可能会对药品的质量或纯度、安全、鉴别、剂量产生负面影响的【误操作】【污染】。例如。。。

Calibration/Inspection/

Checking not done

Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***

没有做校正/检查

【自动化】【机械的】【电子的】设备没有根据书面程序来进行日常【校正】【检查】【核查】。该书面程序应设计以保证其适当工作。例如。。。

Lack of written stability program

There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***

缺乏书面的稳定性试验计划

没有书面的稳定性试验计划用以评估药品的稳定性特征。例如。。。

Control procedures to monitor and validate performance

"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, *** "

监控和验证性能的控制程序

未建立控制程序来对可能会引起在制物料和药品特性变化的生产工艺进行【监控产出】【验证性能】