fda制剂厂检查指南

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1、GUIDETOINSPECTIONSOFDOSAGEFORMDRUGMANUFACTURER'S-CGMPR'SNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).I.INTRODUCTIONThisdocumentisintendedtobeageneralguidetoin

2、spectionsofdrugmanufacturerstodeterminetheircompliancewiththedrugCGMPR's.ThisguideshouldbeusedwithinstructionsintheIOM,otherdruginspectionguides,andcomplianceprograms.AlistoftheinspectionguidesisreferencedinChapter10oftheIOM.Someoftheseguidesare:uGuidetoInspectionsofBulkPharmaceuticalChem

3、icals.uGuidetoInspectionsofHighPurityWaterSystems.uGuidetoInspectionsofPharmaceuticalQualityControlLaboratories.uGuidetoInspectionsofMicrobiologicalPharmaceuticalQualityControlLaboratories.uGuidetoInspectionsofLyophilizationofParenterals.uGuidetoInspectionsofValidationofCleaningProcesses.

4、uGuidetoInspectionsofComputerizedSystemsinDrugProcessing.uGuidelineonGeneralPrinciplesofProcessValidation.II.CURRENTGOODMANUFACTURINGPRACTICEREGULATIONSPrescriptionvs.Non-prescriptionAlldrugsmustbemanufacturedinaccordancewiththecurrentgoodmanufacturingpracticeregulationsotherwisetheyareco

5、nsideredtobeadulteratedwithinthemeaningoftheFD&CAct,Section501(a)(2)(B).RecordsrelatingtoprescriptiondrugsmustbereadilyavailableforreviewinaccordancewithSec.704(a)(1)(B)oftheFD&CAct.IftheproductisanOTCdrugwhichiscoveredbyanNDAorANDA,FDAmayreview,copyandverifytherecordsunderSec.505(k)(2)of

6、theFD&CAct.However,iftheproductisanOTCdrugforwhichthereisnoapplicationfiledwithFDA,thefirmisnotlegallyrequiredtoshowtheserecordstotheinvestigatorduringaninspectionbeingconductedunderSection704oftheFD&CAct.Nonetheless,allmanufacturersofprescriptionandOTCdrugsmustcomplywiththedrugCGMPRrequi

7、rements,includingthoseinvolvingrecords.Theinvestigatorshouldreviewtheserecordsaspartoftheinspectionindeterminingthefirm'scompliancewiththeCGMPregulations.Onrareoccasions,afirmmayrefusetoallowreviewofOTCrecordsstatingtheyarenotlegallyrequiredto.Whilethefirmmaybeunder