Application of Multivariate Tools in Pharmaceutical Product Development to Bridge Risk Assessment to Continuous Verification in a Quality by Design Environment

An important aspect of a quality by design approach to pharmaceutical product formulation and process development is continuous quality verification. This is an innovative way of validating the process where manufacturing performance is continuously monitored, evaluated and adjusted as necessary. For new drug products, the body of knowledge accumulated through the development cycle and formalised via risk assessment forms the natural basis of this activity. This paper shows how multivariate tools can be used as part of a continuous quality verification approach for a new drug product relying on the information that summarises the control strategy, i.e. the subset of critical variables selected via risk assessment and the related proven acceptable ranges determined during developmental studies.