HereisanadditionalparagraphyoucanincludeintheICHQ14AnalyticalProcedureDevelopment(draft)documenttofurtherdescribetheprocess:Thedevelopmentofananalyticalprocedureshouldbebasedonasystematicandscientificapproachthatconsiderstheintendedpurposeofthemethod,thecharacteristicsoftheanalyte,andthematrixofthesample.Arisk-basedapproachshouldbeemployedtoidentifyandevaluatecriticalmethodparametersthatmayimpactthemethodperformance.Methoddevelopmentexperimentsshouldbedesignedtounderstandtherelationshipbetweenthesecriticalparametersandthemethodperformancecharacteristics.Theknowledgegainedduringdevelopmentshouldbedocumentedandusedtoestablishanappropriatecontrolstrategyfortheanalyticalprocedure.Theprocedureshouldberobustenoughtoaccommodateexpectedvariationsinmaterials,instruments,analysts,andenvironmentalconditionswhilestillmeetingitsintendedpurpose.
