Applying quality by design to vaccine development - BioProcess ...

Control Strategy Vocabulary 1TerminologyQuality AttributeCritical Quality Attribute(CQA)Less Critical QualityAttributeAcceptance CriteriaPerformance AttributeDefinitionA physical, chemical, biological or microbiological property orcharacteristic of the product whose variability might have potentialimpact on the safety and efficacy of the product. At early stages ofdevelopment some of these are liley to be “potential CQAs”A physical, chemical, biological or microbiological property orcharacteristic of the product that should be within an appropriatelimit, range or distribution to ensure the desired product quality (ICHQ8 (R2))A quality attribute determined through risk analysis to be less criticalto assurance of desired product quality efficacy and safetyNumerical limits, ranges or other suitable measures for acceptancewhich the DS or DP or intermediate materials should meet toconform with the specification of the results of analytical proceduresA physical, chemical, biological or microbiological property orcharacteristic of the product whose variability might have a potentialimpact on process performance25 From Clone to Clinic®