What is FDA’s risk-based approach to CGMP?
The risk-based approach to CGMP aims at effective allocation of FDA resources applied to regulatory review, compliance, and inspection. For example, the frequency and/or scope of inspections will be reduced for firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems. In addition, FDA expects that applying a risk-based approach to the product quality review process will facilitate continuous improvement in pharmaceutical manufacturing.
