Abstract
The vital part of any pharmaceutical manufacturing is that quality cannot be tested into products; i.e., quality should be built in by design. QbD is a systematic approach to pharmaceutical development to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provides scientific understanding to support the establishment of the design space, product and process specifications, and manufacturing controls along with quality risk management. This ultimately leads to understand the impact of raw materials i.e. critical material attributes (CMA), critical process parameters (CPP) on the Critical Quality Attributes (CQA’s). As a result of all understanding we can monitor and update manufacturing process to assure consistent product quality. This systematic approach to product development and manufacturing has received a great deal from traditional approach, which was extremely empirical. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) into review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment.
