Abstract

Abstract The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. The guidelines of ICH from Q8 to Q11 have discussed QbD implementation in pharmaceutical product formulation development. ICH Q11 is a clear discussion about QbD approach for API (Active Pharmaceutical Ingredient) synthesis with examples. Pharmaceutical firms increased the number of product development by using different scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). The main key tools of AQbD are identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM), TQM (Total Quality Management), DOE (Design of Experiments). Implementation of AQbD simultaneously in analytical development will improve the ability of production of high quality products which will minimize the risks during every step of manufacturing and analysis of products.

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