FDA制剂生产厂检查指南

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1、DosageFormDrugManufacturerscGMPs(10/93)FDA制剂生产厂检查指南GUIDETOINSPECTIONSOFDOSAGEFORMDRUGMANUFACTURERS・CGMPRSNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonneLThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesf

2、ororonanyperson(s).注：此指南是FDA检查官和其工作人员的参考资料。此文件不约束FDA,也不赋予任何人任何权利，特权，利益或豁免权。I.简介ThisdocumentisintendedtobeageneralguidetoinspectionsofdrugmanufacturerstodeterminetheircompliancewiththedrugCGMPR's.ThisguideshouldbeusedwithinstructionsintheIOM,otherdruginspectiong

3、uides,andcomplianceprograms-AlistoftheinspectionguidesisreferencedinChapter10oftheIOM.Someoftheseguidesare:该文件旨在为检查药品生产厂家提供一个总体性的指导，以决定他们是否符合纱物生产的cGMP法规。该指南应该与IOM(InvestigationsOperationsManual,即检查操作手册)，其他的药品检查指南，及法规符合性程序中的指导一起使用。在IOM的第十章屮提供了一个检查指南清单，其屮有：oGuide

4、toInspectionsofBulkPharmaceuticalChemicals.o原料药检杳指南oGuidetoInspectionsofHighPurityWaterSystems.o高纯水系统检查指南oGuidetoInspectionsofPharmaceuticalQualityControlLaboratories.o药品QC实验室检查指南oGuidetoInspectionsofMicrobiologicalPharmaceuticalQualityControlLaboratories.o微牛物约

5、品QC实验室检查指南oGuidetoInspectionsofLyophilizationofParenterals.0冻干注射剂检查指南oGuidetoInspectionsofValidationofCleaningProcesses.o清洁验证检查指南oGuidetoInspectionsofComputerizedSystemsinDrugProcessing.o制药过程中的计算机化系统检查指南oGuidelineonGeneralPrinciplesofProcessValidation.o工艺验证总体原则

6、指南II.CURRENTGOODMANUFACTURINGPRACTICEREGULATIONSII.CGMPPrescriptionvs.Non-prescription处方药和非处方药AlldrugsmustbemanufacturedinaccordancewiththecurrentgoodmanufacturingpracticeregulationsotherwisetheyareconsideredtobeadulteratedwithinthemeaningoftheFD&Cact,Section50

7、1(a)(2)(B).RecordsrelatingtoprescriptiondrugsmustbereadilyavailableforreviewinaccordancewithSec.704(a)(1)(B)oftheFD&CAct.IftheproductisanOTCdrugwhichiscoveredbyanNDAorANDA,FDAmayreview,copyandverifytherecordsunderSec.505(k)(2)oftheFD&CAct.However,iftheproductis

8、anOTCdrugforwhichthereisnoapplicationfiledwithFDA,thefirmisnotlegallyrequiredtoshowtheserecordstotheinvestigatorduringaninspectionbeingconductedunderSection704oftheFD&CAct.N