S.B. Udugade*, B.V. Udugade, T.A. Mandhare
Assistant Professor, Satara College of Pharmacy, Satara, (MH) India-415004
A B S T R A C T
Quality by design is vital part of the modern approach to pharmaceutical quality. The present article gives information about the concept of Quality by Design (QbD) and illustrates how it is helpful to ensure pharmaceutical quality. The elements of quality by design are discussed in this article. The QbD is a systemic approach to design and develop formulation and manufacturing process to guarantee specified product quality. QbD assist to both industry and FDA for pharmaceutical development. QbD approach is based on the concept of building the quality into product not testing it. A company can constantly monitor its manufacturing process to guarantee product quality consistently. QbD provides the scientific configuration to identify all critical attributes of a drug formulation and manufacturing process.
Keywords: Critical Quality Attributes (CQA), Design Space, Quality by design (QbD), Risk assessment, Target Product Quality Profile (TPQP).