Quality By Design In Pharmaceutical Product Development
Keywords:
product profile (QTPP), Process analysis technology (PAT), Critical process parameter (CPP), Quality by Design (QbD), Pharmaceutical product development, Critical quality attributes (CQA), Quality targetAbstract
The current strategy for pharmaceutical quality is called "Quality by Design." This essay outlines the application of pharmaceutical quality by design, or QbD, in the creation of new pharmaceutical products. It describes the Quality by Design and identifies some of its constituent parts. Every unit operation has its own set of process parameters and quality criteria. The prospects and procedures associated with Quality by Design for pharmaceutical products development in manufacturing of tablets are explained. Pharmaceutical development seeks to create high-quality products and production processes that reliably yield the desired product performance. Quality ought to be incorporated into items by design rather than being tested into them. Key components of Quality by Design, as well as the Quality goal product profile and essential quality criteria, are included. Further it is explained with a scientific example conducted by US FDA case study on QbD approach in brief for an immediate-release dosage form for the drug acetriptan and it differentiates the traditional approach vs QbD approach.
