Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Shivani Kshatriya, Heena Ninama, Mitali Dalwadi, Dr. Umesh Upadhyay

Abstract: Quality by Design is the current method for quality of pharmaceuticals. The purpose of the pharmaceutical development is to design a quality product and its manufacturing method to constantly supply the intended overall performance of the product. Quality can't be examined into products however quality have to be built in through design. It is an important part of the current technique to pharmaceutical quality. Under this idea of QbD during designing and improvement of a product, it is important to define preference product overall performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify important quality attributed (CQA). On the premise of this we will design the product components and process to satisfy the product attributes. This results in understand the effect of raw materials [critical material attributes (CMA)], critical process parameters (CPP) at the CQAs and identity and control sources of variability.

Keywords: Quality by design, Analysis, Regulatory