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2022 ISPE Annual Meeting & Expo

SES105b - Applying Patient Centric Strategies to Quality Specifications

Oct 31, 2022 11:00am ‐ Oct 31, 2022 12:30pm


The science and risk/knowledge-based concepts outlined in ICH Q8-Q12 and impurity management guidance in ICH Q3D and ICH M7 encourage a holistic approach for developing a product control strategy by establishing functional relationships between process parameters and material quality attributes to set specification criteria and limits. Under this paradigm, product quality should be confirmed rather than controlled by the drug substance and drug product specifications.

Reliance on batch history as the justification for impurity limits is no longer the only or necessarily the appropriate option. Drug substance and drug product specification acceptance criteria should be set in consideration of upstream controls, downstream controls, impact to other critical quality attributes, impact to the downstream critical process parameters, and most importantly, potential impact to critical quality attributes associated with patient safety and drug product efficacy. This presentation will discuss potential changes to ICH Q6A/B that would embrace a patient-centric approach to specification limit setting.


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