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Lessons from CDER's Quality Management Maturity Pilot Programs.

Jennifer Maguire1, Adam Fisher2, Djamila Harouaka2

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Keywords:
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Area of Science:

  • Pharmaceutical Manufacturing
  • Regulatory Science
  • Quality Management Systems

Background:

  • The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) initiated pilot programs to evaluate drug manufacturing quality management maturity (QMM).
  • Mature quality systems are crucial for proactive vulnerability detection, problem prevention, and fostering continuous improvement in pharmaceutical manufacturing.
  • Enhancing QMM can bolster supply chain resilience, robustness, and help mitigate drug shortages.

Purpose of the Study:

  • To assess the feasibility and effectiveness of evaluating the quality management maturity of drug manufacturing establishments.
  • To gather insights into the QMM assessment process, scoring, assessor conduct, and participant perceptions.
  • To inform the development of a comprehensive CDER QMM program based on lessons learned.

Main Methods:

  • Conducted two pilot programs between October 2020 and March 2022.
  • Assessed seven U.S. establishments producing finished dosage forms and eight foreign establishments producing active pharmaceutical ingredients.
  • Collected data on assessment processes, scoring, assessor behaviors, and participant feedback.

Main Results:

  • Participating establishments identified strengths, weaknesses, and improvement areas not previously detected through internal audits or Current Good Manufacturing Practice (CGMP) inspections.
  • The pilot programs provided valuable lessons regarding the QMM assessment framework, including scoring and reporting.
  • Establishments reported that the QMM assessments offered a new perspective on their quality systems.

Conclusions:

  • The CDER QMM pilot programs yielded significant insights into assessing and improving drug manufacturing quality.
  • Lessons learned will guide the ongoing development of a robust QMM program to enhance drug supply chain integrity.
  • The findings underscore the value of external assessments in identifying opportunities for quality system enhancement in pharmaceutical manufacturing.