Designation:E2363−14StandardTerminologyRelatingtoProcessAnalyticalTechnologyinthePharmaceuticalIndustry1ThisstandardisissuedunderthefixeddesignationE2363;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisterminologycoversprocessanalyticaltechnologyinthepharmaceuticalindustry.TermsaredefinedastheyareusedrelativetothePATframeworkinthepharmaceuticalindustry.Termsthataregenerallyunderstoodandincommonusageoradequatelydefinedinotherreadilyavailableeferencesarenotincludedexceptwhereparticulardelineationtoprocessanalyticaltechnologymaybemoreclearlystated.1.2Thisterminologyisthereforeintendedtobeselectiveoftermsusedgenerallyinprocessanalyticaltechnologyasitisappliedinthepharmaceuticalindustryandpublishedinanumberofdocuments,suchasthoselistedinthesucceedingsections.ThelistingisalsointendedtodefinetermsthatappearprominentlywithinotherrelatedASTMstandardsanddonotappearelsewhere.1.3Thedefinitionsaresubstantiallyidenticaltothosepub-lishedbytheU.S.FoodandDrugAdministrationandotherauthoritativebodies,suchasISO,IEC,ITU,andnationalstandardsorganizations.1.4Thisterminologysupplementscurrentdocumentsonterminologythatconcentrateonprocessanalyticaltechnologyasitisappliedinthepharmaceuticalindustry.1.5Anincreasingnumberofproductdesignationsanddesignationsforchemical,physical,mechanical,analytical,andstatisticaltestsandstandardsarecomingintocommonusageintheliterature,regulatoryenvironment,andcommerceassociatedwithprocessanalyticaltechnologyinthepharma-ceuticalindustry.Section2liststhosedocumentsreferencedinthisterminology.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.2.ReferencedDocuments2.1ASTMStandards:2E456TerminologyRelatingtoQualityandStatisticsE869TestMethodforPerformanceEvaluationofFuelEthanolManufacturin...
