FDA 制剂生产厂检查指南.doc

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1、DosageFormDrugManufacturerscGMPs(10/93)FDA 制剂生产厂检查指南GUIDETOINSPECTIONSOFDOSAGEFORMDRUGMANUFACTURER'S-CGMPR'SNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).注：此指南是FDA检查

2、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,otherdruginspectionguides,andcomplianceprograms.Alistoftheinspectionguidesisreferenc

3、edinChapter10oftheIOM.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药物生产的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的第十章中提供了一个检查指南清单，其中有：oGuidetoInspectionsofBulkPharmaceuticalChemicals. o原料药检查指南oGuidetoInspectionsofHighPurityWaterSystems. o

4、高纯水系统检查指南oGuidetoInspectionsofPharmaceuticalQualityControlLaboratories. o药品QC实验室检查指南oGuidetoInspectionsofMicrobiologicalPharmaceuticalQualityControlLaboratories. o微生物药品QC实验室检查指南oGuidetoInspectionsofLyophilizationofParenterals. o冻干注射剂检查指南oGuidetoInspectionsofValidationofCleaningProcesses. o清洁验证检

5、查指南oGuidetoInspectionsofComputerizedSystemsinDrugProcessing. o制药过程中的计算机化系统检查指南oGuidelineonGeneralPrinciplesofProcessValidation. o工艺验证总体原则指南II.CURRENTGOODMANUFACTURINGPRACTICEREGULATIONSII.CGMPPrescriptionvs.Non-prescription 处方药和非处方药Alldrugsmustbemanufacturedinaccordancewiththecurrentgoodmanufac

6、turingpracticeregulationsotherwisetheyareconsideredtobeadulteratedwithinthemeaningoftheFD&Cact,Section501(a)(2)(B).RecordsrelatingtoprescriptiondrugsmustbereadilyavailableforreviewinaccordancewithSec.704(a)(1)(B)oftheFD&CAct.IftheproductisanOTCdrugwhichiscoveredbyanNDAorANDA,FDAmayreview,copyan

7、dverifytherecordsunderSec.505(k)(2)oftheFD&CAct.However,iftheproductisanOTCdrugforwhichthereisnoapplicationfiledwithFDA,thefirmisnotlegallyrequiredtoshowtheserecordstotheinvestigatorduringaninspectionbeingconductedunderSection704o