FDA外用制剂检查指南中英文版

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1、GUIDETOINSPECTIONSOFTOPICALDRUGPRODUCTS局部外用药物检查指南Note:ThisdocumcntisreferencematerialforinvestigatorsandotherFDApersonnel.Thedocumentdoesnotbind（进退两难）FDA,anddoesnoconfer（赠予）anyrights,privileges（特权）、benefits（权益）,orimmunities（豁免）fororonanyperson（s）.a：该指南是FDA检查官和其他工作人员的参考材

2、料。该指南不是约束FDA,但也不赋予任何人特权，利益或豁免的权利。I.PURPOSE（目的）Thepurposeofthisguideistoprovidefieldinvestigators,whoarefcimiliarwiththeprovisions（食品）oftheCurrentGoodManufacturingPractice（CGMP）regulationsforpharmaceuticals,withguidanceoninspectingsclcctedfacets（方而）oftopical（局部的）drugprod

3、uctproduction.Thesubjectscoveredintheguidearegenerallyapplicabletoallformsoftopicaldrugproducts,includingthosethatareintendedtobesterile（无菌的）.However,thisguidedoesnotaddress（介绍）everyproblemareathcittheinvestigatormayencounter（碰见）,noreverypolicythatpertainsto（附属）topicald

4、rugproducts.该指南的目的是向熟悉食品CGMP规程的检察官提供药品CGMP的指导，提供局部外用药物检查方面的指南。该指南中涵盖的内容适用于所有剂型的局部外用药物，包扌舌那些无菌产品。然而，该指南未能介绍检察官可能遇到的每个问题领域，也不适用局部外用药物的每项政策。II.INTRODUCTION（介绍）Thisinspectionalguideaddressesseveralproblemareasthatmaybeencounteredintheproductionoftopicaldrugproductspolency（效

5、价）,activeingredientuniformity（均一^性）,physicalcharacteristics,microbialpurityandchemicalpurity.Theguidealsoaddressesproblemsrclatingtothegrowingnumberoftransdcrmal（经皮吸收）products.Ifanewdrugpre-approvalinspectionisbeingconducted,thenanexaminationofthefiledmanufacturingandco

6、ntroldata,andcorrespondenceshouldbeaccomplishedearlyintheinspection.Aswithotherpre-approvalinspections,themanufacturingandcontrolsinfonnationfiledintherelevantcipplicationshouldbecomparedwiththedatausedforclinicalbatchesandforproduction（validation）batchcs.Filedproductio

7、ncontroldatashouldbespecificandcomplete.该检查指南介绍了局部外用药物可能遇到的一些问题，如效价、活性成分的均一性、物理性质、微生物纯度和化学纯度。该指南也涉及了越来越多的有关药物经皮吸收的问题。如果正在进行一个新药的审批前检查，早期应完成现场工艺和控制试验数据，以及相关内容的检查。至于其他的检查，提交的有关申请屮生产工艺和现场控制的内容应与临床批次和生产（验证）批次数据比较。现场生产控制数据应具休和完整。TTT.POTENCYUNIFORMITY（效价均一性）Activeingredientso

8、lubility（溶剂性）andparticlesize（颗粒度）aregenerallyimportantingrcdientcharacteristicsthatneedtobecontrolledtoassurep