fda原料藥gmp指南

1、FDA原料藥GMP指南TableofContents目錄1.INTRODUCTION1.簡介1.1Objective1.1目的1.2RegulatyApplicability1.2法規(guī)的適用性1.3Scope1.3范圍2.QUALITYMANAGEMENT2.質(zhì)量管理2.1Principles2.1總則2.2ResponsibilitiesoftheQualityUnit2.2質(zhì)量部門的責(zé)任2.3ResponsibilityfProdu

2、ctionActivities2.3生產(chǎn)作業(yè)的職責(zé)2.4InternalAudits(SelfInspection)2.4內(nèi)部審計（自檢）2.5ProductQualityReview2.5產(chǎn)品質(zhì)量審核3.PERSONNEL3.人員3.1PersonnelQualifications3.人員的資質(zhì)3.2PersonnelHygiene3.2人員衛(wèi)生3.3Consultants3.3顧問4.BUILDINGSFACILITIES4.建筑和

3、設(shè)施4.1DesignConstruction4.1設(shè)計和結(jié)構(gòu)4.2Utilities4.2公用設(shè)施4.3Water4.3水4.4Containment4.4限制4.5Lighting4.5照明4.6SewageRefuse4.6排污和垃圾4.7SanitationMaintenance4.7衛(wèi)生和保養(yǎng)5.PROCESSEQUIPMENT5.工藝設(shè)備5.1DesignConstruction5.1設(shè)計和結(jié)構(gòu)5.2EquipmentMai

4、ntenanceCleaning5.2設(shè)備保養(yǎng)和清潔5.3Calibration5.3校驗5.4ComputerizedSystems5.4計算機控制系統(tǒng)6.DOCUMENTATIONRECDS6.文件和記錄6.1DocumentationSystemSpecifications6.1文件系統(tǒng)和質(zhì)量標(biāo)準(zhǔn)6.2EquipmentcleaningUseRecd6.2設(shè)備的清潔和使用記錄6.3RecdsofRawMaterialsInterm

5、ediatesAPILabelingPackagingMaterials6.3原料、中間體、原料藥的標(biāo)簽和包裝材料的記錄6.4MasterProductionInstructions(MasterProductionControlRecds)6.4生產(chǎn)工藝規(guī)程（主生產(chǎn)和控制記錄）6.5BatchProductionRecds(BatchProductionControlRecds)6.5批生產(chǎn)記錄12.6PeriodicReviewof

6、ValidatedSystems12.6驗證系統(tǒng)的定期審核12.7CleaningValidation12.7清洗驗證12.8ValidationofAnalyticalMethods12.8分析方法的驗證13.CHANGECONTROL13.變更的控制14.REJECTIONREUSEOFMATERIALS14.拒收和物料的再利用14.1Rejection14.1拒收14.2Reprocessing14.2返工14.3Rewking1

7、4.3重新加工14.4RecoveryofMaterialsSolvents14.4物料與溶劑的回收14.5Returns14.5退貨15.COMPLAINTSRECALLS15.投訴與召回16.CONTRACTMANUFACTURERS(INCLUDINGLABATIES)16.協(xié)議生產(chǎn)商（包括實驗室）17.AGENTSBROKERSTRADERSDISTRIBUTSREPACKERSRELABELLERS17.代理商、經(jīng)紀(jì)人、貿(mào)易商

8、、經(jīng)銷商、重新包裝者和重新貼簽者17.1Applicability17.1適用性17.2TraceabilityofDistributedAPIsIntermediates17.2已分發(fā)的原料藥和中間體的可追溯性17.3QualityManagement17.3質(zhì)量管理17.4RepackagingRelabelingHoldingofAPIsIntermediates17.4原料藥和中間體的重新包裝、重新貼簽和待檢17.5Stabil

9、ity17.5穩(wěn)定性17.6TransferofInfmation17.6信息的傳達(dá)17.7HlingofComplaintsRecalls17.7投訴和召回的處理17.8HlingofReturns17.8退貨的處理18.SpecificGuidancefAPIsManufacturedbyCellCultureFermentation18.用細(xì)胞繁殖發(fā)酵生產(chǎn)的原料藥的特殊指南18.1General18.1總則18.2CellBank

10、MaintenanceRecdKeeping18.2細(xì)胞庫的維護(hù)和記錄的保存18.3CellCultureFermentation18.3細(xì)胞繁殖發(fā)酵18.4HarvestingIsolationPurification18.4收取、分離和精制18.5ViralRemovalInactivationsteps18.5病毒的去除滅活步驟19.APIsfUseinClinicalTrials19.用于臨床研究的原料藥19.1General1