Pharmaceutical technology · 2005 · 20 citations · 0 references
EngineeringQuality ManagementRisk ManagementProcess ControlProcess Systems EngineeringQuality EngineeringCritical Process ParametersIn-process ControlProcess EngineeringProcess Quality AssuranceProcess Risk ManagementProcess SynthesisProcess ParametersProcess Quality RiskProcess Risk AssessmentRegulatory RequirementsRegulatory Requirements ManagementRegulatory Risk Assessment
A stepwise, process riskassessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.