抽象的

Quality by Design

Sushila D. Chavan, Nayana V. Pimpodkar, Amruta S. Kadam, Puja S.Gaikwad

Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. QbD is best key to build a quality in all pharmaceutical products. Under this concepts of be throughout design and growth of product, it is important to identify desire product performance report [Target product profile (TPP), Quality Target product profile (QTPP)] and identify critical quality attributes (CQA). To recognize the impact of raw material [critical material attributes (CAM)], critical process parameters (CPP) on the CQAs and identification and control sources of changeability. The plan of pharmaceutical development is to design a quality products and its manufacturing process always deliver the future performance of the product. The base of Quality by design is ICH Guidelines Q8 for Pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems.