D1S07-Twum-v1.2-FINAL.pdf

1、An Update on CDERs Quality Management Maturity ProgramEric TwumRegulatory SpecialistOffice of Quality Surveillance,Office of Pharmaceutical QualityCDER|U.S.FDAGeneric Drug Forum April 22,2026www.fda.gov2Agenda What is CDERs QMM Program?Why develop CDERs QMM Program?What were the Lessons Learned from

2、 First Cohort of the QMM Prototype Assessment Protocol Evaluation Program?Next Stepswww.fda.gov3What is CDERs QMM Program?The QMM Program evaluates and scores a drug manufacturing establishments level of maturity in five practice areas.CDERs Quality Management Maturity(QMM)Program encourages drug ma

3、nufacturers to implement quality management systems and practices that go beyond current good manufacturing practice(CGMP)requirements.www.fda.gov4CDERs QMM Program Goals Foster a strong quality culture mindset.Recognize establishments with advanced quality management practices and acknowledge estab

4、lishments that strive to continually improve quality management practices.Identify areas where quality management practices can be enhanced and provide suggestions for opportunities for growth.Minimize risk to product availability to assure reliable market supply.www.fda.gov5Five QMM Practice AreasM

5、anagement Commitment to QualityBusiness ContinuityAdvanced PQSTechnical ExcellenceEmployee Engagement and Empowermentwww.fda.gov6Drug manufacturing establishments achieve higher levels of quality management maturity when they successfully integrate business and manufacturing operations with quality

6、management practices and technological advancements to optimize product quality,enhance supply chain reliability,and drive continual improvement.www.fda.gov Root Cause:The market does not recognize and reward manufacturers for“mature quality systems”that focus on continuous improvement and early det