 April 21, 2022
Dear International Colleague,
The FDA’s Center for Drug Evaluation and Research (CDER) has long held a vision for 21st century pharmaceutical quality which has been described as a “maximally efficient agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.”
Fully realizing this vision requires moving beyond Current Good Manufacturing Practice (CGMP) standards, the minimum manufacturing standards to legally market drug products in the United States, and closer to a state in which manufacturers have consistent, reliable and robust business processes to achieve quality objectives and promote continual improvement. This state is what CDER’s Office of Pharmaceutical Quality (OPQ) describes as Quality Management Maturity, which OPQ says is essential for stable U.S supply chains. Simple adherence to CGMP standards does not indicate, for example, that a firm is investing in improvements or deploying statistical process control to prevent supply disruptions, OPQ said in a new white paper on the topic, “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals.”
CDER has proposed the development of a rating system that will help incentivize drug manufacturers to achieve QMM at their facilities. A QMM rating system could inform regulators and purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. QMM ratings could also support increased flexibility for manufacturers to make post-approval manufacturing changes with less regulatory oversight, incentivizing continual improvement.
To engage stakeholders on QMM, CDER’s Small Business and Industry Assistance will host a QMM workshop on May 24 and 25. In Part 1 of this QMM workshop, FDA subject matter experts and guest speakers will:
- Provide a vision of CDER’s QMM program
- Explain the importance of QMM and its potential to improve supply chain decisions and reduce drug shortages
- Discuss the relationship between QMM, quality metrics, ICH Q12 Lifecycle Management, and advanced manufacturing
- Share the perspectives of industry participants in CDER’s QMM pilot programs (including a foreign pilot)
- Describe lessons learned from CDER’s QMM pilot programs
In Part 2 of this QMM workshop, FDA subject matter experts and guest speakers will:
- Describe how quality ratings have positively impacted medical device manufacturers through CDRH’s Case for Quality program
- Discuss existing quality ratings programs and their impact on industries
- Present research on financial and other risks associated with QMM ratings
- Provide perspectives from academia and industry on the importance of QMM
- Share opportunities for stakeholders to use QMM ratings
- Discuss perspectives of impacted stakeholders
WORKSHOP
Quality Management Maturity Workshop
Date: May 24-25, 2022
Day 1: Tuesday, May 24, 1:00 PM - 4:00 PM ET
Day 2: Wednesday, May 25, 1:00 PM - 4:00 PM ET
This webinar is FREE
AUDIENCE
- Purchasers of drugs or active pharmaceutical ingredients
- Pharmaceutical manufacturers
- International regulators
- Experts on quality management systems
- Government agencies involved in the pharmaceutical supply chain
- Payors and pharmaceutical benefits managers
FDA RESOURCES
This webinar is part of the SBIA Regulatory Education for Industry (REdI) series.
|
