PDA Letter Article

Risk Management Shines Light on ICH Q12 Use for Biologics

by Jose C. Menezes, PhD, 4Tune Engineering

World Management

Wanting pharma companies to consider quality-by-design (QbD) elements throughout a product’s entire lifecycle, including post-approval changes, through integration of risk- and knowledge-based approaches, seems to have become a global regulatory expectation. For biologics, however, using these approaches is more complex and companies cannot simply adopt the same strategies used for traditional small molecules.