Module 3 - Strategic case studies in practice

ICH Guidelines

• Q8 – Pharmaceutical Development (R2) • Q9 – Quality Risk Management • Q10 – Pharmaceutical Quality System • Related ICH Guidelines • Q11 – Development and manufacture of drug substances • Q12 –Technical and Regulatory Considerations for Pharmaceutical Product Life Cycle Management • Q13 –Continuous manufacturing of drug substances and drug products (concept paper) • Q14 –Analytical procedure development (concept paper)