Analytical quality by design (AQBD): new paradigm for analytical method development

Quality of a finished product is gauged by compliance of certain predetermined specifications. This is ascertained by validated analytical procedures carried out by quality control personnel and laid down by the Quality Assurance (QA) department of a pharmaceutical company. In the present scenario, testing of the finished product alone is not sufficient, but emphasis is on ‘Total Quality Management’ through in-process testing and analysis. To achieve this goal, Quality by Design (QbD) concept has already been introduced and practised by all countries following guidelines of International Conference on Harmonization (ICH guidelines). Other features like Quality Risk Management, Pharmaceutical Quality System and Process Analytical Technology (PAT) guidelines are also being now introduced and integrated into analytical method development processes. They are very popularly accepted as AQbD (Analytical Quality by Design) concepts by the industry. Though not officially circulated, this new paradigm has attracted appreciation from all concerned and is evident by increasing publications in this field. The day may not be far off when this becomes official. Till then, certain observations and suggestions are compiled and presented through this review paper.