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Risk Management Shines Light on ICH Q12 Use for Biologics

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.