Pharmaceutical Quality by Design
Quality indicates fit to use. The quality of any pharmaceutical product means that it should be contamination free and its therapeutic benefits are reproducible as per the claim on its label. Its quality is evaluated In vitro and In vivo. The in vitro performance of a product is evaluated by Quality by design and this In vitro product performance gives information of In vivo product performance, so Quality by design assures about the whole product performance. It is a systematic approach to development starting with pre-planned agendas and centres over the understanding product, process and process control, on the basis of established scientific technology and quality risk management. It has come to practice to promote safe and effective drug supply and also claims to significantly improve manufacturing quality performance.