Understanding cGMPs For Phase 1 Investigational Drugs

By Daniel Carpenito

Understanding the regulatory landscape for early-phase drug development is crucial for biotech and pharmaceutical companies. The FDA offers a risk-based framework for Phase 1 investigational drugs, exempting them from the full scope of commercial manufacturing requirements. This flexibility allows companies to streamline processes and reduce costs while still ensuring safety and quality.

By using a structured risk assessment and implementing a strategic commissioning program, companies can make sure their facilities and equipment meet FDA expectations without the need for extensive qualification. This targeted approach enables faster progress to first-in-human trials, providing a clear path to operational readiness that can seamlessly scale as a product advances to later phases of development.