The FDA Quality Management Maturity (QMM) program has generated an increased interest in quality culture in the pharmaceutical industry. The Center for Drug Evaluation and Research (CDER) has established a program to encourage manufacturers of drugs (including biologics), with the stated purpose of implementing QMM programs to:

  • Foster a strong quality culture mindset;
  • Recognize establishments that have advanced QMM practices and acknowledge those that are striving to improve QMM practices;
  • Identify areas of improvement for QMM practices and provide suggestions for improvement; and
  • Minimize risks to product availability to ensure market supply of needed drugs.

 

The FDA published a notice in the Federal Register on January 25, 2024 (here), inviting establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program to evaluate quality practices throughout their organizations.

Assessment tools are a framework for assessing the maturity of quality management systems throughout an organization in these practice areas:

  • Management Commitment to Quality
  • Business Continuity
  • Advanced Pharmaceutical Quality System (PQS)
  • Technical Excellence
  • Employee Engagement and Empowerment

 

The ISPE Biotechnology Conference that took place in Boston last month included multiple pharmaceutical industry representatives who presented topics on QMM. They covered a number of different perspectives on this important initiative. Although many aspects of QMM are of interest, the role of leadership in the establishment of quality culture is key for sustainability. Leaders are responsible for consciously setting quality culture for their companies and in personal goals for individuals within their organizations. Quality culture is formed by recognizing that people are foundational and that there is a need to develop behaviors and mindsets in order to maintain a quality culture in the workplace. Leaders can inculcate a quality mindset in the following ways:

  • Managers connect with employees and their activities.
  • Leaders demonstrate genuine concern for the quality of work, awareness of the impact of behaviors, drive for continuous improvement, and trust in openness and communication.
  • Management shares quality goals through avenues such as visual monitors of quality performance, Gemba walks, coaching and mentoring, and leadership behavior that models a vision of quality adherence.
  • Leadership encourages decision making at the lowest level possible, including employees at all levels in thinking about quality.
  • Employers match people with the right skills for the roles, but also select them for characteristics, such as passion and creativity.

 

The FDA initiative on QMM has led to tools such as the ISPE’s Advancing Pharmaceutical Quality (APQ) awareness program (more information here). Industry leaders are paving the way for a beyond-the-cGMPs approach to quality culture. Enhancement of quality culture within a company can lead to improved patient safety, reduced costs due to reduction in rejects, defects, and deviations, and increased employee engagement and retention of skilled workers.

If your firm is interested in an assessment of your progress regarding QMM or an assessment of your quality culture, Lachman can help you! Reach out to us today at LCS@LachmanConsultants.com to schedule a consultation.