QbD

Generics , ANDA

1. QTPP(Quality target product profile) relating to Quality , safety, efficacy of the product Identification of critical quality attributes ( CQAs ) Identification of critical product attributes ( CPPs ) Design development product/process Understand and express mathematically CQAs & CPPs relationship Develop a design space Design & implement control strategy Product specification is based on understanding of product formulation and performance variables impact process performance Continual improvement of the product lifecycle Risk review quality management Initial risk assessment Risk assessment Using prior knowledge, risk management tool, DOE, Multivariate analysis, etc. Risk control Robust process is developed Design process measurement to allow in-line, on-line , at-line monitoring of CQAs CPPs are adjusted by measuring CQAs QbD approach, combining design space development and risk management tools