Abstract

Analytical method development and validation by QbD approach – A review

Quality by Design is the modern approach for quality of pharmaceuticals. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It is an essential part of the modern approach to pharmaceutical quality. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognize the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability.


Author(s): Sachin B. Gholve, Rani R. Ajgunde, Omprakash G. Bhusnureand Sanjay S. Thonte

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