DosageFormDrugManufacturerscGMPs(10/93)FDA制剂生产厂检查指南GUIDETOINSPECTIONSOFDOSAGEFORMDRUGMANUFACTURERS-CGMPRSNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(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ThisdocumentisintendedtobeageneralguidetoinspectionsofdrugmanufacturerstodeterminetheircompliancewiththedrugCGMPRs.Thisguideshouldbeusedwithin