翻译：JULIA来源：Julia法规翻译

04.10.

TheRoleofVisualInspectionintheReleaseofParenterals

注射剂放行中目视检查的作用

Accordingtotherequirementsofpharmacopoeias(e.g.EUorUS),batchesofsterileinjectablesmustbe%visuallyinspected.Thistest,whichistoberatedasanin-processcontrol,mustbevalidated;becauseofitsprobabilisticnature.However,itisnot%freefromerrors.Thatmeansthatthediscoveryofdefectslikeparticles,forexample,isaquestionofprobability.Visualinspectioncannotruleoutthepresenceofdefectsinatestedbatch.Thehigheroneraisestheprobabilityofdetection,thehighertheso-calledFalseRejectRategoes,meaningtherejectionofactuallyerror-freetestpieces.

根据药典（例如欧洲药典和美国药典）的要求，无菌注射剂批次必须经过%目视检查。鉴于目视检查的必然性，此检查归类为中控检查，必须经过验证。但是，这并不表示%无误，也就是说检出如颗粒物是有一定概率的。目视检查并不能排除受测批次中仍存在缺陷。检出的概率越高，则所谓的错误拒收率就会越高，竟未着实际无误测试件拒收越多。

Now,howisonetohandlethefactthattheresultofanofficiallyrequiredbatchtestmightnotbe%correct?

那么要如何处理这种官方要求的检测可能并不能得到%正确结果的情况呢？

Forthis,theUSPharmacopoeiaintendedanadditionalsamplinginspectionofcontainerswhichwerefoundtobeadequateinchapter.Aftermuchdelay(becauseofUS-internaldiscussions),theadditionalchapter1waspublishednow,too.Intendedareso-calledAQLtests(acceptablequalitylimit).Dependingonthenumberofcontainersinabatch,adictatedAQLtabledefinesthesizeofthesample,whichisthenvisuallyinspectedandinwhichonlyafixednumberofdefectsmaybefound.Thenumbertherebydependsonthecriticalityofthedefect.ThenumberofpermittedcriticaldefectsinanAQLtestshouldbe0,numberspermittedformajorandminordefectsarealsospecifiedbytheAQLlimit.TheUSPsetthatlimitat0.65.Thishasthegreatadvantageofmakingthepharmacopoeiarequirementmeasurablethatbatchesofparenteralsmustbepracticallyoressentiallyfreeofparticles.

对此，美国药典认为应于对容器进行更多的取样检查，而不仅局限于认为足够的内容。在拖了很久之后（因为美国内部讨论），现在1也已经发布了，其内容是所谓的AQL测试（可接受质量限度）。依据一个批次中容器数量的不同，有一个专门的AQL表格规定了样本数，这些数量的样本会进行目视检查，所允许发现的缺陷数量有规定。该数量取决于缺陷的关键程度。在一个AQL测试中所允许的关键缺陷数量应为0，允许的主要缺陷和轻微缺陷数量也由AQL限度规定了。USP设定的限度为0.65。这有一个很大的优点就是让药典要求变得可测量，注射剂的批次必须实际或基本上没有颗粒物。

TheEuropeanPharmacopoeiadoesnotincludearequirementaboutAQLtesting,sofar.Still,AQLtestingisconsideredGoodIndustryPracticeinEurope,aswell,andisperformedbymanypharmaceutical