FDA’s Quality Management Maturity Program:Why should CDMOs adhere to the new CDER’s Rating System?
Ensuring the safety and efficacy of pharmaceutical products is paramount in the healthcare industry, making the FDA’s Quality Management Maturity (QMM) program and CDER’s proposed rating system crucial for Contract Development and Manufacturing Organizations (CDMOs) to adopt. Understanding and adhering to these initiatives can empower CDMOs to ensure high-quality pharmaceuticals, prevent drug shortages, improve regulatory compliance, and build a reputation for reliability and excellence.
In this white paper, we delve into the QMM program’s benefits, the rating system’s evaluation criteria, advantages for CDMOs, challenges they may encounter, and actionable steps to overcome these hurdles and achieve excellence in their quality management systems.
Download our white paper to gain insights on:
- The Significance of FDA’s Quality Management Maturity (QMM) Program.
- CDER’s Proposed Rating System, designed to incentivize drug manufacturers to achieve QMM and measure their performance on a 10-point scale.
- Advantages for CDMOs to adhere to the QMM program and achieving high scores on the rating system.
- Challenges CDMOs may face in attaining high scores.
- How investing in QMM can help CDMOs build a reputation for quality and reliability in the pharmaceutical industry, differentiating themselves from competitors and gaining consumer trust.