国际药学与生命科学研究与发展杂志

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Applications of Quality by Design (QbD) in formulation development

Devendra Ridhurkar

The main objective of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Pharmaceutical industry realized that Quality by Design (QbD) principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and    significantly reduce postapproval changes and also helps to build a quality in all pharmaceutical products. Hence the application of QbD in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. Target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are the key elements of QbD. Throughout designing and development of a product with QbD, it is essential to define desire product performance profile Target product profile (TPP), Target product Quality profile(TPQP) and identify Critical quality attributed (CQA) leads to recognize the impact of raw material,Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability.