International Journal of All Research Education & Scientific Methods

An ISO Certified Peer-Reviewed Journal

ISSN: 2455-6211

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A Short Review on Quality by Design (QbD)

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A Short Review on Quality by Design (QbD)

A Short Review on Quality by Design (QbD)

Author Name : Sonali R. Kote*, Samruddhi K. Gharmalkar, Payal R.Pokale, Sarita S. Pawar

ABSTRACT Quality by Design is the modern approach for quality of pharmaceuticals. In recent years pharmaceuitical regulatory documents has stressed the significance of the QbD to ensure that product quality is built in by design. The purpose of this article is to discuss pharmaceutical Quality by Design and descibe how it be used in pharmaceutical quality product development. QbD is essential in regulatory requirements and also in implementation of new concepts such as a design space, ICH guidelines.i.e.Q8 Pharmaceutical development, Q9 Quality Risks Management, and FDA's Process Analytical Technology (PAT).