Designation:E2500−13StandardGuideforSpecification,Design,andVerificationofPharmaceuticalandBiopharmaceuticalManufacturingSystemsandEquipment1ThisstandardisissuedunderthefixeddesignationE2500;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideisapplicabletoallelementsofpharmaceu-ticalandbiopharmaceuticalmanufacturingsystemsincluding:facilityequipment,processequipment,supportingutilities,associatedprocessmonitoringandcontrolsystems,andauto-mationsystemsthathavethepotentialtoaffectproductqualityandpatientsafety.1.2Forbrevity,thesearereferredtothroughouttherestofthisguideasmanufacturingsystems.1.3Thisguidemayalsobeappliedtolaboratory,information,andmedicaldevicemanufacturingsystems.1.4Thisguideisapplicabletobothnewandexistingmanufacturingsystems.Theapproachmaybeusedfortheimplementationofchangestoexistingsystems,andtheircontinuousimprovementduringoperation.1.5Thisguideisapplicablethroughoutthelife-cycleofthemanufacturingsystemfromconcepttoretirement.1.6Thisstandarddoesnotaddressemployeehealthandsafety,environmental,orothernon-GxPregulations.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E2363TerminologyRelatingtoProcessAnalyticalTechnol-ogyinthePharmaceuticalIndustryE2474PracticeforPharmaceuticalProcessDesignUtilizingProcessAnalyticalTechnologyE2475GuideforProcessUnderstandingRelatedtoPharma-ceuticalManufactureandControlE2476GuideforRiskAssessmentandRiskControlasitImpactstheDesign,Development,andOperationofPATProcessesforPharmaceuticalManufactureE2537GuideforApplicationofContinuousQualityVerifi-cationtoPharmaceuticalandB...
