QbD is systematic approach to development and begins with predefined objective and emphasises product, process understanding and process control, based on sound science and quality risk management. QbD enhance the assurance of product safety and effective drug supply to customer QbD also offer promise to significantly improves manufacturing quality performance QbD having below steps- 1. Define Target product profile (use, safety and efficacy of the product) 2. Define Target quality product profile - used by the formulator and process engineer as quantitative surrogate for the aspects of clinical safety during development. Gather relevant prior knowledge about drug substance, critical raw materials and process operation in to knowledge space. Use risk assessment to prioritise for knowledge gaps for further investigation. 3. Design formulation and identify Critical quality attributes/ Critical material attributes of final product, which required to be controlled to...