The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future development of the FDA rating system. It helps to characterize quality management maturity (QMM), which would allow a cross-sectional comparison of manufacturers.

As the QMM ratings enable health systems and other payers/purchasers of medications to differentiate among manufacturers, those who voluntarily choose to disclose their facility ratings could benefit from a competitive advantage. Manufacturers must submit a request to participate in the program. The Agency will select up to nine (9) applicants for each pilot program. Participation in the QMM API program is limited to foreign manufacturing facilities whereas, for the FDF program, it is limited to domestic manufacturing facilities.

To administer the pilot program, the Agency (FDA) will identify a third-party contractor and conduct the assessment of the QMS for the manufacturing facility, accompanied by the FDA staff. The Agency provides a rating to the facility after the results of the QMM assessments. Some of the assessments under the QMM pilot programs include the following:

  • Supply Chain Management
  • Risk Management
  • Safety, Environmental, and Regulatory Compliance
  • Manufacturing Strategy and Operations
  • Performance Management and Continual Improvement
  • Inventory Management
  • Customer Experience
  • Workforce Management
  • Management Review and Responsibility
  • Planning
  • Quality Culture

The Agency believes quality metrics as the key elements that determine manufacturers' effort to increase the maturity of QMS and hence, continue to develop the Quality Metrics Program. Such programs benefit manufacturers who demonstrate quality management maturity (QMM) with an enhanced quality management system (QMS) that exceeds the minimum standards specified in current good manufacturing practice (GMP) regulations and focuses on continual improvement. The Agency also exercises a more flexible Regulatory approach for producing high-quality drug products without extensive Regulatory oversight. 

Hence, manufacturers with a clean FDA inspection record for over the past 5 years are advised to apply for the program. To ensure that all your processes/products are aligned with applicable quality and compliance, consult a Regulatory expert.


Related Posts by Category