CPDS strongly recommends to align with the FDA Quality Management Maturity program (QMM).

The FDA’s QMM program promises a radical shake-up of how pharmaceutical quality is perceived, measured and rewarded.

CPDS proces QM methods will bring you to the high maturity level.

Learn how to align with the program and use it to your advantage!

‘ Introduction
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to
promote quality management maturity (QMM) at drug manufacturing establishments.
CDER is developing its QMM Assessment Tool (protocol and rubric) to evaluate how
effectively establishments monitor and manage quality and quality systems. The QMM
program aims to encourage drug manufacturers to implement quality management
practices that go beyond current good manufacturing practice (CGMP)requirements.1
The goals of this program are fourfold:
1. Foster a strong quality culture mindset
2. Recognize establishments that have advanced quality management practices
and acknowledge establishments that strive to continually improve quality
management practices
3. Identify areas where quality management practices can be enhanced and
provide suggestions for growth opportunities
4. Minimize risks to product availability to assure reliable market supply
Adopting mature quality management practices supports a more reliable drug supply
chain by reducing the occurrence of quality-related failures and improving the ability
of establishments to maintain performance during expected and unexpected supply
chain disruptions. Integrating business and manufacturing operations with quality
practices and technological advancements can help achieve higher levels of maturity.
This can optimize manufacturing process performance and product quality, enhance
supply chain reliability, and foster proactive continual improvement. The next critical
step in implementing this program is developing the protocol that assesses the QMM
of manufacturing establishments. This prototype assessment protocol will be tested
and refined during the 2024 calendar year”