新老版本的对比我还没时间，挖个坑吧，没准儿有好心人能做这个对比呢。
A.Additional Laboratory Testing
额外的实验室测试
A full-scale OOSinvestigation may include additional laboratory testing beyond the testing performed in Phase I. These include (1)retesting a portion of the original sample and (2) resampling.
全面的OOS调查可能包括第一阶段测试之外的其他实验室测试。这些测试包括（1）重新测试部分原始样品和（2）重新取样测试。
1.Retesting
重新测试
Part of theinvestigation may involve retesting of a portion of the original sample. The sampleused for the retesting should be taken from the same homogeneous material that was originally collected from the lot,tested, and yielded the OOS results. Fora liquid, it may be from theoriginal unit liquid product or composite of the liquid product; for a solid, it may be an additional weighingfrom the same sample composite prepared for the original test.
作为调查的一部分，可能涉及对部分原始样本的重新测试。用于重新测试的样品应从最初从批次中收集、测试并产生OOS
Situations whereretesting is indicated include investigating testing instrument malfunctions or to identifya possible samplehandling problem, for example, a suspected dilution error. Decisions to retest should be based on the objectives of thetesting and sound scientificjudgment. It is often important for the predefined retesting plan to include retests performed by an analystother than the one who performed the originaltest. A second analystperforming a retest should be at least as experienced and qualified in the method as the original analyst.
需要重新检测的情况包括调查检测仪器故障或确定可能的样品处理问题，例如，疑似稀释错误。复验的决定应基于检测的目标和合理的科学判断。对于预定义的重新测试计划来说，包括由分析人员而不是执行原始测试的分析人员执行的重新测试通常是很重要的。执行重测的第二名分析员应该至少与原分析员对该方法一样有经验和资格。
The CGMP regulationsrequire the establishment of specifications, standards, sampling plans,test procedures, and other laboratory control mechanisms (§211.160).
CGMP要求建立规范、标准、抽样计划、检测程序和其他实验室控制机制(§211.160)。
FDA inspections haverevealed that some firms use a strategy of repeated testing until a passing result is obtained, thendisregarding the OOS results without scientific justification. Thispractice of “testing into compliance” is unscientific and objectionable underCGMP. The maximumnumber of reteststo be performed on a sample shouldbe specified in advance in a written standard operating procedure (SOP). The number may vary depending upon the variability of the particular testmethod employed, but should be basedon scientifically sound principles. Thenumber of retests should not be adjusted dependingon the results obtained. The firm'spredetermined retesting procedures should containa point at which the additional testing ends and the batch is evaluated. If the resultsare unsatisfactory at this point, the batch is suspect and must be rejected orheld pending further investigation (§211.165(f)). Any deviation from thisSOP should be rare and done inaccordance with § 211.160(a), which states that any deviations from written specifications, sampling plans, testprocedures, or other laboratory control mechanisms shall be recorded and justified. In such cases, before starting additional retesting, a protocol should be prepared (subject toapproval by the QU) that describes the additional testing to be performed and specifies the scientific and/ortechnical handling of the data.
FDA检查发现，一些公司使用重复检测的策略，直到获得合格的结果，然后在没有科学依据的情况下无视OOS结果。在CGMP下，这种“检测到符合性”的做法是不科学的，是令人反感的。对样品进行重测的最大次数应事先在书面标准操作程序(SOP)中规定。数目可能因所采用的特定试验方法的可变性而异，但应以科学合理的原则为基础。重新测试的数量不应根据获得的结果进行调整。公司预先确定的复检程序应该包含一个额外检测结束和批次评估的点。如果此时结果不令人满意，则该批次有嫌疑，必须拒收或等待进一步调查(§211.165(f))。任何偏离本SOP的情况都应很少发生，且应按照§211.160(a)进行，§211.160(a)规定，任何偏离书面规范、抽样计划、测试程序或其他实验室控制机制的情况都应记录下来并加以证明。在这种情况下，在开始额外的复检之前，应准备一份方案(经QU批准)，说明要进行的额外检测，并规定数据的科学和/或技术处理。
9
如果出现明确的实验室错误，重新测试结果将替代原始测试结果。但是，必须保留所有原始数据（§211.180），并记录解释【9】。该记录应由相关人员简签并注明日期，包括错误讨论和监督意见。（有关实验室调查的更多详细信息，请参见本指南第三节。）
【9 见§211.68和211.188。另见FDA行业数据完整性和药品CGMP符合性指南(2018年12月)。】
If no laboratory orcalculation errors are identified in the first test, there is no scientific basis for invalidating initial OOS resultsin favor of passing retest results. Alltest results, both passing and suspect, should be reported10
如果在第一次检测中没有发现实验室或计算错误，则为通过复检结果而使初始OOS
【10 换句话说，所有的数据都要按照§211.188和211.192的要求进行报告，例如，质量控制报告、批记录、分析证书。】
2.Resampling
重新取样
While retesting refersto analysis of the original, homogenous sample material, resampling involves analyzing a specimen from any additional units collected as part of theoriginal sampling procedure or from a new sample collected from the batch,should that be necessary.
复验指的是对原始的、均匀的样品材料进行分析，而重取样则涉及分析作为原始抽样程序一部分的任何额外单元的样品，或必要时从批次中收集的新样品。
The original samplefrom a batch should be sufficiently large to accommodate additional testing in the event an OOS result isobtained. In some situations,however, it may be appropriate tocollect a new sample from the batch. Controlmechanisms for examination ofadditional specimens should be in accordance with predetermined procedures and samplingstrategies (§ 211.165(c)).
批次的原始样品应足够大，以便在获得OOS结果时进行额外的测试。然而，在某些情况下，从批次中收集新样品可能是合适的。额外样本检验的控制机制应符合预先确定的程序和抽样策略(§211.165(c))。
When all data havebeen evaluated, an investigation might conclude that the original sample was prepared improperly and wastherefore not representative of the batch quality (§ 211.160(b)(3)). Impropersample preparation might be indicated, for example, by widely varied results obtained from several aliquots of anoriginal composite (after determiningthere was no error in the performance of the analysis). Resampling should be performed by the same qualified, validated methods that were usedfor the initial sample. However,if the investigation determines that the initial sampling method was inherently inadequate, a new accurate samplingmethod must be developed, documented, and reviewed andapproved by the QU (§§ 211.160 and 211.165(c)).
报告检测结果
Practices used inreporting and interpretation of test results include (1) averaging and (2)outlier tests.
用于报告和解释测试结果的做法包括(1)平均和(2)异常值测试。
1.Averaging
结果求均值
There are bothappropriate and inappropriate uses of averaging test data during original testingand during an OOS investigation:
在原始检测和OOS调查期间，平均检测数据有适当和不适当的使用:
a.Appropriate uses
适当使用
Averaging data can bea valid approach, but its use depends upon the sample and its purpose.For example, in an optical rotation test, several discrete measurementsare averaged to determine the opticalrotation for a sample, and this average is reported as the test result. If the sample can be assumed to be homogeneous, (i.e., anindividual sample preparationdesigned to be homogenous), using averages can provide a more accurate result. In the case of microbiologicalassays, the U.S. Pharmacopeia (USP) prefers the use of averages becauseof the innate variability of the biological test system.
平均数据可能是一种有效的方法，但它的使用取决于样本及其目的。例如，在一个旋光度测试中，对几个离散的测量值取平均值以确定样品的旋光度，这个平均值作为测试结果报告。如果可以假设样品是均匀的()(USP)
It should be notedthat a test might consist of a specific number of replicates to arrive at a result.For instance, an HPLC assay result may be determined by averaging thepeak responses from a number ofconsecutive, replicate injections from the same preparation (usually 2 or 3). The assay result would be calculated using the peak responseaverage. This determination isconsidered one test and one result.1112
应该注意的是，一项测试可能包括特定数量的重复以得出结果。例如，HPLC分析结果可通过对来自同一制备液的多个连续重复注射（通常为2或3）的峰值响应求平均来确定。使用峰值响应平均值计算分析结果。该测定被视为一次试验和一个结果【11】。这与批次中不同部分的分析（旨在确定批次内的可变性）以及同一同质样品的多个完整分析存在明显差异。使用复制来获得单个可报告的结果、以及使用的具体重复次数应在QU批准的书面试验方法中规定【12】。方法中还应规定重复进样可变性的验收限值。
【11 进一步澄清请参见第五节b注意事项。】
【12 在本文件中使用的术语“可报告结果”是指最终的分析结果。该结果在书面批准的测试方法中得到适当的定义，并从原始样本开始，从该方法的一次完整执行中得到。】
Unexpected variationin replicate determinations should trigger remedial action as required by § 211.160(b)(4). If acceptance limits for replicatevariability are not met, the test results should not be used.
重复测定的意外变化应触发§211.160(b)(4)要求的补救措施。如果不满足重复可变性的可接受限度，则不应使用测试结果。
In some cases, aseries of complete tests (full run-throughs of the test procedure), such as assays, are part of the test method. It may be appropriate to specify in thetest method that the average of thesemultiple assays is considered one test and represents one reportable result. In this case, limitson acceptable variability among the individual assay results should be based on the known variability of themethod and should also be specified in the test methodology.13 A set of assayresults not meeting these limits should not be used.
某些情况下，一系列完整的测试(测试程序的完整运行)——例如分析过程——是测试方法的一部分。可以在试验方法中规定，将这些多个分析的平均值视为一次试验，并代表一个可报告的结果。。在这种情况下，单个分析结果之间可接受的变异性的限制应基于方法的已知变异性，并应在试验方法中规定不符合这些限度的一组化验结果不应使用【13】。
【13 参见脚注11。】
只有在产生OOS结果的原始测试中使用这些平均化测试数据时，才可以在OOS调查中使用该处理方式。
b.Inappropriate uses
不当使用
Reliance on averaginghas the disadvantage of hiding variability among individual test results.For this reason, all individual test results should normally be reportedas separate values. Where averaging of separate tests isappropriately specified by the test method, asingle averaged result can be reported as the final test result. In some cases, a statistical treatment of the variability of results isreported. For example, in a test fordosage form content uniformity, thestandard deviation (or relative standard deviation) is reported with the individualunit dose test results.
依赖平均值的缺点是隐藏了单个测试结果之间的可变性。因此，所有单独的测试结果通常应作为单独的值报告。如果测试方法适当地指定了各个测试的平均值，则可以报告单个平均值作为最终测试结果。在某些情况下，报告结果的可变性的统计处理——例如在剂量剂型含量均匀性试验中的标准偏差(或相对标准偏差)——与单个单位剂量试验结果一起报告。
Averaging can alsoconceal variations in different portions of a batch, or within a sample. For example, the use of averages isinappropriate when performing powder blend/mixture uniformity or dosage form content uniformity determinations. In these cases, testing is intended to measure variability within theproduct, and individual results provide the information for such an evaluation.
平均化数值还可以隐藏批次不同部分或样本内的变化。例如，在进行粉末混合/
In the context ofadditional testing performed during an OOS investigation, averaging the result(s) of the original test thatprompted the investigation with additional retest or resample results obtained during the OOS investigation is notappropriate because it hides variabilityamong the individual results. Relyingon averages of such data can be particularlymisleading when some of the results are OOS and others are within specifications. It is critical that the laboratory provide all individualresults for evaluation andconsideration by the QU, which is responsible for approving or rejecting, e.g.,drug products, in-process materials(§ 211.22).
在OOS调查期间进行的额外测试中，将引发调查的原始测试结果与OOS调查期间获得的额外重新测试或重新取样结果进行平均是不合适的，因为它隐藏了单个结果之间的可变性。当一些结果是OOS，而另一些结果在规范范围内时，依赖这些数据的平均值可能会产生特别的误导。至关重要的是，实验室应提供所有单独的结果，以供负责批准或拒绝（如药品、中间体材料）的QU进行评估和考虑（§211.22）。
For example, in anassay of a finished drug with a specification of 90 to 110 percent, an initial OOS result of 89 percent followedby additional retest results of 90 percent and 91 percent would produce an average of 90 percent. While this average would meet specification,14
例如，在对规格为90%至110%的成品药物进行分析时，初始OOS结果为89%，然后再进行90%和91%的重新测试，平均结果为90%。虽然这个平均值符合规范要求， 附加测试结果也倾向于确认原始OOS结果【14】。
【14 在做出批次处置决定时，公司评估，低检测值是否预示在产品标明的有效期末期导致低效价的失败，这很重要。】
However, in anothersituation with the same specifications, an initial OOS result of 80 percent followed by additional test resultsof 85 percent and 105 percent would also producean average of 90 percent but present a much different picture. These results do not confirm the original OOS result but show high variability and may not be reliable. In both examples,the individual results, not the average, should be used to evaluate the qualityof the product.
然而，在相同规格的另一种情况下，初始OOS结果为80%，随后的额外测试结果为85%和105%，也会产生平均90%，但呈现出一种截然不同的画面。这些结果并不确认原始OOS结果，但显示出高可变性，可能不可靠。在这两个例子中，应该使用单独的结果，而不是平均值来评估产品的质量。
2.Outlier Tests
离群测试
The CGMP regulationsrequire that statistically valid quality control criteria include appropriate acceptance and/or rejectionlevels (§ 211.165(d)). On rareoccasions, a value may be obtainedthat is markedly different from the others in a series obtained using a validated method. Such a value may qualify as a statistical outlier. An outlier may result from a deviation from prescribed testmethods, or it may be the result of variability in the sample. It shouldnever be assumed that the reason for an outlier is error in the testing procedure, rather than inherent variability in the sample beingtested.
CGMP法规要求统计上有效的质量控制标准包括适当的接受和/或拒绝水平（§211.165（d））。在极少数情况下，可能会获得与使用验证方法获得的系列中的其他值明显不同的值。这样的值可能符合统计异常值的条件。离群值可能是由于偏离规定的试验方法，也可能是由于样品的可变性。绝不能假设异常值的原因是测试程序中的错误，而不是被测试样本中固有的可变性。
Outlier testing is astatistical procedure for identifying from an array those data that are extreme. The possible use of outlier testsshould be determined in advance. Thisshould be written into SOPs for datainterpretation and be well documented. TheSOPs should include the specificoutlier test to be applied with relevant parameters specified in advance. The SOPs should specify theminimum number of results required to obtain astatistically significantassessment from the specified outlier test.
离群值测试是一种统计程序，用于从数组中识别极端数据。应提前确定离群测试的可能用途。应将其写入SOP中进行数据解释，并做好记录。SOP应包括具体的异常值测试，并提前规定相关参数。SOP应规定从指定的异常值测试中获得统计显著性评估所需的最小结果数。
For biological assayshaving a high variability, an outlier test may be an appropriate statistical analysis to identify thoseresults that are statistically extreme observations. The USP describesoutlier tests in the general chapter on Design and Analysis of Biological Assays (USP<111>). In these cases,the outlier observation is omitted from calculations. The USP also states that “arbitrary rejection or retention of anapparently aberrant response can be aserious source of bias…the rejection of observations solely on the basis of their relative magnitudes, withoutinvestigation as to cause, is a procedure to be used sparingly” (USP <111>).
对于具有高可变性的生物测定，异常值检验可能是一种适当的统计分析，以确定那些结果是统计上的极端观察。USP(USP<111>)
《美国药典》还指出，“……”(USP <111>)
For validated chemicaltests with relatively small variance, and if the sample being tested can be considered homogeneous (forexample, an assay of a composite of a dosage form drug to determine strength), an outlier test is only astatistical analysis of the data obtainedfrom testing and retesting. It willnot identify the cause of an extreme observation and, therefore, should not be used to invalidate the suspect result.
对于方差相对较小的验证化学试验，如果被测样品可以被认为是同质的（例如，测定剂型药物的复合物以确定强度），离群值试验仅是对从试验和重新试验中获得的数据进行统计分析。它不会确定极端观察的原因，因此不应用于使可疑结果无效。
Occasionally, anoutlier test may be of some value in understanding how discordant from a data set a result is, but can be usedsolely in an informational capacity in the course of an investigation todetermine the distance of a resultfrom the mean.15
偶尔，离群值测试可能对了解结果与数据集的不一致性有一定价值，但只能在调查过程中以信息容量来确定结果与平均值的距离【15】。
【15 异常值检验不应用于使化学分析结果无效。参见美国新泽西州联邦地方法院诉巴尔实验室公司案 Civil Action Number 92-1744,OPINION, February 4, 1993.】
Outlier tests have no applicability in cases where the variability inthe product is what is beingassessed, such as for content uniformity, dissolution, or release ratedeterminations. In these applications, a value perceived to be an outlier may infact be an accurate result of a nonuniform product.
在评估产品的可变性的情况下的检验数据，不适用离群值测试。例如含量均匀性、溶出度或释放率测定，则离群值测试不适用。在这些应用中，被认为是异常值的值实际上可能是不均匀产品的准确结果。
When using thesepractices during the additional testing performed in an OOS investigation, the laboratory will obtainmultiple results. It is againcritical for the laboratory to provide all test resultsfor evaluation and consideration by the QU in its final disposition decision. In addition, when investigation by acontract laboratory16
当在OOS调查的附加测试中使用这些做法时，实验室将获得多重结果。同样至关重要的是，实验室应提供所有检测结果，供QU在其最终处置决定中进行评估和考虑。此外，当合同化验室的调查不能确定可分配的原因时，所有的检测结果应在分析证书上报告给客户【16】。
【16 FDA还建议将OOS调查报告提供给客户。】
结束调查
To conclude theinvestigation, the results should be evaluated, the batch quality should be determined, and a release decision shouldbe made by the QU. The relevant SOPsshould be followed in arriving atthis point. Once a batch has beenrejected, there is no limit to further testing to determine the cause of the failureso that a corrective actioncan be taken.
调查结束时，应对结果进行评估，确定批次质量，并由QU做出是否放行的决定。此时应遵循相关sop。一旦批次被拒绝，就可以进行进一步的检测，以确定失败的原因，以便采取纠正措施
A.Interpretation of Investigation Results
调查结果的解释
The QU is responsiblefor interpreting the results of the investigation. An initial OOS result does notnecessarily mean the subject batch fails and must be rejected. The OOS result should be investigated, and the findings of theinvestigation, including retest results, should be interpreted to evaluate the batch and reach a decision regarding release or rejection(§ 211.165).
QU负责解释调查结果。初始OOS结果不一定意味着目标批次失败而必须拒收。应对OOS结果进行调查，并对调查结果（包括复验结果）进行解释，以评估该批次，并就放行或拒收做出决定（§211.165）。
In those instanceswhere an investigation has revealed a cause, and the suspect result is invalidated, the result should not be usedto evaluate the quality of the batch or lot.Invalidation of a discretetest result may be done only upon the observation and documentation of a testevent that can reasonably be determinedto have caused the OOS result.
在调查发现原因且可疑结果无效的情况下，该结果不应用于评估批次或全部批的质量。只有在观察并记录了可合理确定导致OOS
In those cases wherethe investigation indicates an OOS result is caused by a factor affecting the batch quality (i.e., an OOS result isconfirmed), the result should be used in evaluating the quality of the batch or lot. Aconfirmed OOS result indicates that the batch does not meet established standards or specificationsand should result in the batch's rejection, in accordance with § 211.165(f), and proper disposition. For inconclusive investigations — in caseswhere an investigation (1) does notreveal a cause for the OOS test result and (2) does not confirm the OOS result — the OOS result should be givenfull consideration in the batch or lot disposition decision.
如果调查表明OOS结果是由影响批次质量的因素引起的（即，OOS结果得到确认），则应使用该结果评估批次或批次的质量。根据§211.165（f），经确认的OOS结果表明该批次不符合既定标准或规范，应导致该批次拒收，并进行适当处置。对于未能归因调查——如果调查（1）未揭示OOS测试结果的原因，且（2）未确认OOS结果——则在批次或全部批的处置决策中应充分考虑OOS结果。
In the first case (OOS confirmed), the investigation changes from anOOS investigation into a batchfailure investigation, which must be extended to other batches or products thatmay have been associated with the specific failure (§ 211.192).
在第一种情况下（OOS结果已确认），调查从OOS调查转变为批次故障调查，必须扩展到可能与特定故障相关的其他批次或产品（§211.192）。
In the second case (inconclusive), the QU might still ultimatelydecide to release the batch. For example, a firm mightconsider release of theproduct under the following scenario:
在第二种情况下（未确认），QU可能最终决定放行该批次。例如，公司可能会考虑在以下情况下发布产品：
A producthas an acceptable composite assayrange of 90.0 to 110.0 percent. The initial (OOS)assay result is 89.5 percent. Subsequent sample preparations from theoriginal sample yield the followingretest results: 99.0, 98.9, 99.0, 99.1, 98.8, 99.1, and 99.0 percent. A comprehensive laboratory investigation (Phase1) fails to reveal any laboratory error.Review of eventsduring production of the batch reveals no aberrations or indication ofunusual process variation.17
产品的可接受分析范围为90.0%至110.0%。初始（OOS）检测结果为89.5%。原始样品的后续样品制备产生以下重新测试结果：99.0%、98.9%、99.0%、99.1%、98.8%、99.1%和99.0%。综合实验室调查（第1阶段）未能发现任何实验室错误。对该批次生产过程中发生的事件进行审查，没有发现异常或不正常工艺变化的迹象【17】。对生产工艺和产品历史的回顾可以证明该工艺是稳健的。七个通过的复测结果都在所用方法的已知可变性范围内。中控、含量均匀性、溶出度等检验的批结果与通过的复检结果一致。经过彻底的调查后，公司的QU可能会得出结论，最初的OOS结果不能反映该批产品的真实质量。
【17 例如，对工艺变化的评估将确定既定的设备、设施和工艺控制限度是否满足。】
值得注意的是，在这种情况下，最初的、彻底的实验室调查没有找到任何可归因于的原因。然而，如果随后的调查仍然得出结论，OOS结果的来源是与生产工艺无关的原因，作为对这种实验室偏差检测的非典型失败的回应，调查必须包括适当的跟踪和审查，以防止可能导致OOS结果的实验室错误再次发生。
As the above example illustrates, any decision to release a batch,in spite of an initial OOS result thathas not been invalidated, should come only after a full investigation has shownthat the OOS result does not reflectthe quality of the batch. In makingsuch a decision, the QU should always err on the side of caution.
如上例所示，尽管最初的OOS结果没有失效，但任何放行批次的决定都应该在全面调查表明OOS结果不能反映该批次的质量之后做出。在作出这样的决定时，QU应谨慎行事。
B.Cautions
警告
1.Averaging resultsfrom multiple samplepreparations from the original sample
从原始样品中取多个样品制备的平均结果
In cases where a seriesof assay results (intended to produce a single reportable result) are required by the test procedure and some ofthe individual results are OOS, some are within specification, and all are within the known variability of themethod, the passing results are no morelikely to represent the true value for the sample than the OOS results. For this reason, a firm should err on the side of caution and treat the average ofthese values as an OOS result, even ifthat average is within specification. Thisapproach is consistent with the principle outlined in the USP General Notices that an official article shall complywith the compendial standard any timea compendial test is applied.18
如果检测程序要求一系列的检测结果(旨在产生单一的报告结果)，并且一些单独的结果是OOS，一些在规格范围内，并且所有的结果都在方法的已知可变性范围内，通过的结果并不比OOS结果更可能代表样品的真实值。出于这个原因，即使该平均值在规格范围内，公司应该谨慎行事将这些值的平均值视为OOS结果。这种方法与USP凡例中概述的原则是一致的，即任何时候使用药典测试时，药典各论都应符合药典标准【18】。因此，药典测试的个例实施都应该期望产生符合规范的结果。
【18 USP, General notice, Section 7.10，“测试结果，统计和标准”声明“在实验室观察到的分析结果(或从实验测量计算出的)与规定的可接受标准进行比较，以确定其是否符合药典要求。”】
2.Averaging resultsfrom same final sample preparation
同一最终样品制备的平均结果
As noted in theAveraging section (IV.C.1.), there may be cases where the test method specifies appropriate acceptance criteria forvariability and a pre-defined number of replicates from the final diluted sample solution to arrive ata result. For example, an HPLC testmethod may specify both acceptancecriteria for variability and that a single reportable result be determined by averaging the peak responsefrom a number of consecutive, replicate injections from the same test vial. In these cases, and giventhe acceptance criteria for variability are met, the result of any individualreplicate in and of itself should not cause the reportable result to be OOS.
如平均值部分(IV.C.1.)HPLCOOS
3.Borderline resultsthat are within specification
在规范范围内的临界结果
An assay result that islow, but within specifications, should also raise a concern. One cause of the result could be that the batch was not formulated properly. Batches must be formulated with the intent to provide not less than 100percent of the labeled or established amount of active ingredient (§ 211.101(a)). Thiswould also be a situation where the analytical result meets specifications, but caution should be used in the release or reject decision.19
检测结果较低，但在规范范围内，也应引起关注。结果的一个原因可能是该批次配方不正确。各批次的配方必须提供不少于100%的标记或规定量的活性成分（§211.101（a））。在这种情况下，分析结果也符合规范要求，但在决定是否放行时应谨慎【19】。
【19 如ICH行业指南Q1E稳定性数据评估指南(2004)所述，[i]如果在批放行时，一个批次的化验值低于标签要求的100%，则可能在建议的货架期结束前低于较低的接受标准。如果检测结果表明一个批次可能在其有效期之前低于测定标准，则必须采取适当的措施(见211.137和211.165)。】
As with all analyticaltesting conducted to evaluate the quality of a drug, all records pertaining to the OOS test result should be retained. Records must be kept of complete dataderived from all tests performed to ensure compliance with established specifications and standards (§ 211.194).
与所有为评估药物质量而进行的分析测试一样，所有与OOS测试结果有关的记录都应予以保留。必须保存所有测试得出的完整数据记录，以确保符合既定规范和标准（§211.194）。
C.Field Alert Reports
现场警报报告
For those productsthat are the subject of an approved new drug application or abbreviated new drug application, regulations requiresubmitting within 3 working days a field alert report (FAR) of information concerning any failure of adistributed batch to meet any of the specifications established in an application (21 CFR 314.81(b)(1)(ii)).20
对于已批准的新药申请或仿制药申请的产品类别，法规要求在3个工作日内提交一份现场警报报告(FAR)，内容是关于一个分发批次的任何不符合申请中规定的任何规范的信息(21 CFR314.81(b)(1)(ii))【20】。这些产品的OOS检测结果被认为是本规定所述的一种“关于任何不合格的信息”。
Unless the OOS result onthe distributed batch is found to be invalid within 3 days, an initial FAR should be submitted. A follow-up FAR should be submitted when the OOS investigation is completed.
除非在3天内发现已分发批次的OOS结果无效，否则应提交初始的FAR。当OOS调查完成时，应提交后续的FAR。
Field Alert Report Submission Questions and Answers
