Quality by Design approaches to Analytical Method Development

The concept of QbD to the analytical method development is as known AQbD (Analytical Quality by design).It is an informal in the pharmaceutical industry to perform analytical quality by design (AQbD) in method development activity as a part of risk management, pharmaceutical development, and pharmaceutical quality system. Testing of final product is not enough, but prominence is on ‘Total Quality Management’ through in-process testing and analysis is required today. The International Conference for Harmonization (ICH) has announced regulatory guidelines for pharmaceutical development.