(424e) Quality by Design in Generic Drug Development: Process Development and Quality Risk Management

The recent ICH guidelines Q8 (R2)( Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System) outline a comprehensive Quality-by-Design (QbD) approach. For the QbD process development, among the critical elements highlighted in the ICH Q8(R2), the ability of the process to reliably manufacture a product of the intended quality with respect to its clinical performance needs to be assessed. Process development is a systematic evaluation that includes prior knowledge, experimentation, and risk assessment. Such systematic and enhanced product and process understanding in combination with quality risk management could establish an appropriate control strategy which can, for example, include continuous process monitoring and real time feed back controls.

Risk management is integral part of QbD. Evaluation of risk to quality should be based on scientific knowledge and ultimately linked to the safety, efficacy and quality of the drug product to the patient. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk itself.

An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.

This presentation will cover the above features of process development and quality risk management under QbD paradigm along with a case study for illustration.