关于淋洗法验证

《关于淋洗法验证》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。

1、STERISRinsesamplingforCleaningValidationStudies清洁验证中淋洗取样法的研究DestinA.LeBlancRinse-samplingproceduresthatdrawfromthefinalrinsesolutioncanprovideupper-limitestimatesofpotentialcontaminationinsubsequentlymanufacturedproducts.Theprocesscanbeimprovedbyseparatingtheprocessrinsefromthesamplingrinse.

2、Thismayresultinmoreaccurateactualestimates,moreflexibilityinselectinganalyticalprocedures,andmoreflexibilityinchoosingasamplingrinsesolutionthatisdifferentfromtheprocessrinsesolution.Proceduresforsuchdeterminationsdependonadequaterinserecoverystudies.Thisarticledescribesthesestudies.从最终淋洗溶液取样

3、的淋洗液取样程序可以提供后续生产产品中潜在污染物的上限评估。该程序中也可将淋洗工艺和取样工艺分开。选择不同的更加灵活分析规程、选择与淋洗工艺不同的取样淋洗溶剂，均可以得到更准确的结果评估。这些检测程序均基于充分的淋洗回收率研究。本文即描述这些研究ValidationofcleaningprocessesusedforproductcontactsurfacesinpharmaceuticalmanufacturingisrequiredbyFDA.The1993decisionofUSv.BarrLaboratoriesgaveFDAtherighttomandatethat

4、cleaningisacriticalprocessthatmustbevalidated(1).Althoughthisdecisionfocusedmainlyonissuesrelatedtoretestingafterout-of-specificationresults,italsoheldthatFDAhadtherightinthiscasetomandatevalidationofcleaningprocesses.InJuly1992,whilethiscasewasbeinglitigated,theagency’sMid-AtlanticRegionsta

5、ffdevelopedaninternalinspectionguidelineforcleaningvalidation(2).InJuly1993,themoreofficialandstillcurrent“GuidetoInspectionsofValidationofCleaningProcesses”wasissued(3)FDA要求药品生产中对于产品直接接触的表面清洁工艺必须进行验证。1993年美国BarrLaboratories案例（注1）的判决结果中赋予了FDA将清洁规定为关键工艺且必须经过验证的权利。尽管这次决议主要关注的是OOS后的复测相关问题，但仍可认为

6、FDA在这次案例中获得了清洁工艺验证的授权。1992年7月，这场官司还在诉讼期时，中大西洋地区部门开发了清洁验证内部检查指南（注2）。1993年7月，更官方的并且现在仍通行的《清洁验证检查指南》发布了（注3）。The1992Mid-Atlanticguidediscussesthreetypesofsampling:directsurface,rinse,andplacebo.Directsurfaceisratedmostdesirable,rinseisconsideredlessdesirable,andplaceboisconsideredgenerallyunacc

7、eptable.Inthe1993guide,althoughnotexplicitlystated,therelativerankingofthesemethodsisassumedtohold—withdirectsurfacebeingmostdesirableandplacebobeingacceptableonlyifdirectsurfaceorrinsesamplingisalsodone.Tworeasonssupporttheless-desirabledesignationforri