2015财年FDA公布的前十大缺陷

一沙一叶

Cite Id

Reference Number

Short Description

Long Description

Frequency

1105

21 CFR 211.22(d)

Procedures not in writing, fully followed 程序没有书面化，没有完全遵守

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

160

3603

21 CFR 211.160(b)

Scientifically sound laboratory controls科学合理的化验室控制     

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, ***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。。。。   

130

2027

21 CFR 211.192

Investigations of discrepancies, failures不符合性、失败调查

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。。。

124

1451

21 CFR 211.113(b)

Procedures for sterile drug products无菌药品的程序  

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

104

1361

21 CFR 211.100(a)

Absence of Written Procedures 缺失书面程序  

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, ***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。。。

95

1434

21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System环境监控系统

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***无菌工艺区域饿环境条件监控系统不足，例如。。。

83

1883

21 CFR 211.165(a)

Testing and release for distribution检测和放行销售

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, ***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。。。

80

3585

21 CFR 211.110(a)

Control procedures to monitor and validate performance监控和验证性能的控制程序

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, ***没有确立控制程序来监控生产过程的输出、验证性能，可能导致中间产品和药品的品质的差异。

69

1213

21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance清洁/消毒/维护

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, ***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。。。

68

1274

21 CFR 211.68(a)

Calibration/Inspection/Checking not done校验/检查/核对

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

64

1914

21 CFR 211.166(a)

Lack of written stability program

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

63

1435

21 CFR 211.42(c)(10)(v)

Cleaning System

Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***

60

syhorchid

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工作QQ

15年的总结？
出处是哪里？

一沙一叶

工作QQ 发表于 2017-9-5 22:44
15年的总结？
出处是哪里？

FDA官网   

Uwe

读后非常有收获

blueangelhui

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工作QQ

一沙一叶 发表于 2017-9-6 21:09
FDA官网

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