FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.
Emerging Technology Program
FDA meets early with companies developing technologies that may offer significant improvements to pharmaceutical quality and provides recommendations to help support technology development and implementation and anticipated applications. The Emerging Technology Team has considered a wide range of new technologies such as continuous manufacturing, 3D printing, Process Analytical Technology, distributed manufacturing, and artificial intelligence.
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Center for Drug Evaluation and Research (CDER) is preparing a regulatory framework to support the adoption of advanced manufacturing technologies that could bring benefits to patients. Based on engagements through the Emerging Technology Program and elsewhere, the FRAME initiative prioritized four technologies: End-to-End Continuous Manufacturing, Distributed Manufacturing, Point-of-Care Manufacturing, and the use of Artificial Intelligence in manufacturing.
FDA engages foreign regulatory counterparts to coordinate on ways to advance product quality. For example, we work with the International Council on Harmonisation (ICH) to develop harmonized quality standards and facilitate implementation by industry. FDA is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is an international organization dedicated to harmonizing inspection practices and related policies. FDA has also engaged in initiatives such as the Mutual Recognition Agreement to utilize inspectional observations from capable regulatory authorities, reduce duplicative efforts, and focus resources and inspections on facilities that pose the greatest risk. In addition, the FDA is promoting engagement with global regulators under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe.
Concept of Operations (ConOps)
In June 2017, CDER and Office of Regulatory Affairs (ORA) established a ConOps to integrate facility evaluations and inspections for human drugs. See our Q&A page for additional details about how this collaboration will improve consistency, efficiency, and transparency for facility evaluations, and inspections, and regulatory actions.
Quality management maturity (QMM)
CDER is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. CDER is developing its QMM Assessment Tool (protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
FDA requires all drug manufacturers to monitor quality and drive continuous improvement. FDA’s quality metrics webpage provides background on the FDA’s efforts to initiate a voluntary reporting program that can provide key metrics to the FDA.