Quality by design is the modern approach for quality of pharmaceutical. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based holistic and protective approach for development of pharmaceutical product. The purpose of this project is to discuss the pharmaceutical quality by design and describe how it can be used to ensure pharmaceutical quality. Some of the quality by design (QbD) elements include defining target product profile (TPP), Target product quality profile (TPQP) and identify critical quality attributed (CQA). On this basis we can design the product formulation and the process to meet the product attributes. QbD is necessary in regulatory requirement and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management and FDA’s process analytical technology (PAT).
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