Getting Ready for Risk-Based GMPs

Published on: 
BioPharm International, BioPharm International-04-01-2003, Volume 16, Issue 4

by Patrick Clinton, BioPharm International As FDA moves toward a new vision of GMP regulations, BioPharm International asked industry experts some key quextions: What form will risk-based GMPs take? What are the benefits and costs for biotech? Will the change really encourage innovation? And, most important, can FDA leaders get field inspectors to buy into the new approach?