GMP Active Pharmaceutical Ingredients TRS957Annex2

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1、©WorldHealthOrganizationWHOTechnicalReportSeries,No.957,2010Annex2WHOgoodmanufacturingpracticesforactivepharmaceuticalingredients1.Introduction1.1Objective1.2Regulatoryapplicability1.3Scope2.Qualitymanagement2.1Principles2.2Responsibilitiesofthequalityunit(s)2

2、.3Responsibilityforproductionactivities2.4Internalaudits(self-inspection)2.5Productqualityreview3.Personnel3.1Personnelqualifications3.2Personnelhygiene3.3Consultants4.Buildingsandfacilities4.1Designandconstruction4.2Utilities4.3Water4.4Containment4.5Lighting4.

3、6Sewageandrefuse4.7Sanitationandmaintenance5.Processequipment5.1Designandconstruction5.2Equipmentmaintenanceandcleaning5.3Calibration5.4Computerizedsystems6.Documentationandrecords6.1Documentationsystemandspecifications6.2Equipmentcleaninganduserecord6.3Records

4、ofrawmaterials,intermediates,APIlabellingandpackagingmaterials6.4Masterproductioninstructions(masterproductionandcontrolrecords)6.5Batchproductionrecords(batchproductionandcontrolrecords)6.6Laboratorycontrolrecords130TRS957.indd13021.04.1011:036.7Batchproducti

5、onrecordreview7.Materialsmanagement7.1Generalcontrols7.2Receiptandquarantine7.3Samplingandtestingofincomingproductionmaterials7.4Storage7.5Re-evaluation8.Productionandin-processcontrols8.1Productionoperations8.2Timelimits8.3In-processsamplingandcontrols8.4Blen

6、dingbatchesofintermediatesorAPIs8.5Contaminationcontrol9.PackagingandidentificationlabellingofAPIsandintermediates9.1General9.2Packagingmaterials9.3Labelissuanceandcontrol9.4Packagingandlabellingoperations10.Storageanddistribution10.1Warehousingprocedures10.2Di

7、stributionprocedures11.Laboratorycontrols11.1Generalcontrols11.2TestingofintermediatesandAPIs11.3Validationofanalyticalprocedures11.4Certificatesofanalysis11.5StabilitymonitoringofAPIs11.6Expiryandretestdating11.7Reserve/retentionsamples12.Validation12.1Validat

8、ionpolicy12.2Validationdocumentation12.3Qualification12.4Approachestoprocessvalidation12.5Processvalidationprogramme12.6Periodicreviewofvalidatedsystems12.7Cleaningvalidation12.8Val