Analytical_approach_in_QbD_SSPC.44161808.pdf

1 Analytical QbD approach ----Pritesh Dasare Analytical Department (ANDA) SPARC, Baroda. S P A R C 2 Outline Introduction to Quality by Design Analytical approach in Quality by Design S P A R C 3 Quality by Design A scientific approach to design a product and process performance characteristics to meet specific objectives, that are not merely empirically derived from performance of the test batches. S P A R C 4 Analytical approach Analytical methods plays a important role in supporting implementation of QbD in pharmaceutical process development and manufacturing. Analytical testing also plays a prominent role in Pharmaceutical development, risk assessment, process monitoring and control and continuous quality assessment throughout the product life cycle. S P A R C 5 Expectations from an Analytical procedure It is not only a task, but needs to be developed in a way it is expected. It should be suitable for its intended purpose.. The objective of the analytical procedure should be clearly understood that this will govern the validation characteristics which need to be evaluated to prove its intended purpose..... An analytical procedure is a whole (not only a method) which includes sample preparation, well characterized reference materials, robust test procedure and cost effectiveness etc. S P A R C 6 Analytical method and Risk management Risk factor= Severity x Occurrence x Detectability Severity = Effect on Patient Related to safety of efficacy (CQAs) Likelihood of Occurrence = Chance of Failure Related to product, process knowledge and control, also includes uncertainity for new process or process changes Detectability = Ability to Detect a failure Capability of analytical method and sampling considerations. S P A R C 7 Analytical methods-Control strategy QTPP = Quality Target Product Profile, CQA = Critical Quality Attribute Raw material testing Specifications based on product QTPP and CQAs. Effect of