FDA's Quality Management Maturity Program: Why Should CDMOs Adhere To The New CDER's Rating System?

By Rebecca Alcantara, Director, Global Supplier Quality Compliance, Curia

The safety and effectiveness of medications are the bedrock of a healthy healthcare system. This makes the FDA's Quality Management Maturity (QMM) program, along with the proposed rating system from its Center for Drug Evaluation and Research (CDER), a critical initiative for CDMOs to embrace.

Understanding and implementing these programs empowers CDMOs to achieve several key goals. First, they can ensure the consistent production of high-quality pharmaceuticals, minimizing the risk of drug shortages. Second, adhering to QMM principles strengthens regulatory compliance. Finally, CDMOs that excel in the program build a reputation for reliability and excellence, differentiating themselves from competitors and gaining valuable consumer trust.

This white paper dives deeper into the specific benefits of the QMM program for CDMOs. We'll explore the evaluation criteria of CDER's proposed rating system, a valuable tool for benchmarking performance and identifying areas for improvement. The paper also acknowledges the potential challenges CDMOs might face in implementing the program and offers actionable steps to overcome these hurdles. Discover how investing in QMM excellence positions your CDMO for success in the evolving landscape of pharmaceutical quality.