A review on quality by design: A new approach in formulation development

Quality by Design (QbD) refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product life cycle. During designing and development of a product in QbD, a company needs to define desire product performance profile [Target Product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). It also gives comparison between product quality by end product testing and product quality by Quality by Design. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.

Author(s): Rashmi Chaudhari*, Smita Pimple and Pravin Chaudhari

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