Abstract

Question Based Development to Demonstrate Quality by Design and to Facilitate Continued Process Verification

Ajaz Hussain, Consultant/President, Insight Advice & Solutions LLC

Since 2000 the US FDA has continually focused on improving practices in industry and within FDA to truly adopt what is broadly referred to as ‘quality by design’ or QbD. Several important guidance documents are available, such as FDA’s PAT and Process Validation Guidance to ICH Q8-10, and 11; and illustrative case examples provided by several industry segments and also by FDA itself. Yet today the state of QbD adoption and implementation remains variable and uncertain. Recent organizational changes at CDER/FDA have created a new ‘supper’ Office of Pharmaceutical Quality to improve information and knowledge sharing and decision- making; (a) within New and Generic CMC Review function, and (b) between CMC Review and CGMP Compliance functions. ‘Question based Review’ and ‘Continued Process Verification’ are two themes can be expected to have a significant impact over the next several years on how product development, validation and manufacturing is carried out in industry and how FDA will review and inspect these functions. This presentation will provide a means to organize this evolving regulatory context and then discuss how a question based approach to product development can facilitate demonstrating the realization of quality by design in ANDA submissions and effectively leveraged for; (a) rigorous process qualification (stage 1-2-3) and (b) continued process verification.