Analytical Quality by Design

QbD applied to analytical procedure development is termed as Analytical Quality by Design (AQbD). ICH Q14 encompasses the approach of AQbD. Appropriate information from analytical procedure risk assessment and development studies to support the proposed strategy of lifecycle management should be submitted in summarized form in the regulatory submission sections for analytical procedure validation. AQbD elements are Analytical Target Profile (ATP) or Quality Target Method Profile (QTMP), Risk Assessment, Critical Method Parameters (CMP), Critical Quality Attributes (CQA), Method Operable Design Region/Space (MODR) & Method Validation. AQbD being systematic approach develops analytical method by multivariate Design of Experiment (DoE) rather that tedious univariate One Factor at a time (OFAT) concept which gives better understanding of the method and robustness. MODR thus obtained is used to set control strategy of the analytical method which is further validated and proven as fit for use and continuously monitored for improvement. Analytical methods are key part of control strategy with reference to pharmaceutical quality system. Thus implementation of analytical QbD in manufacturing process as control strategy will ensure predetermined performance and product quality. The chapter describes the concept, importance, elements, systematic steps etc. of AQbD. The chapter in depth explains implementation of AQbD with an insight in to the practical aspects giving examples of chromatographic method development.