Module 3 - Strategic case studies in practice

What is Quality by Design (QbD)?  A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (ICH Q8 R2) Systematic Approach Predefined objectives  Define Quality Target Product Profile (QTPP)  Identify Critical Quality Attributes (CQA)

Product and process understanding

 Identify critical material attributes (CMA*) and critical process parameters (CPP)  Establish the functional relationships that link CMA/CPP to CQA  Develop appropriate Control Strategy, including justifications  Science-driven development (scientific literature, prior knowledge, DOEs etc.)

Process control

Sound science

Quality risk management  Risk-based development (ICH Q9) * CMA definition will be given later.

3