Inactive Total Small Business Set-Aside (FAR 19.5)

FDA -20-RFQ- 1228728 Title: Quality Management Maturity Assessments At Up To Nine Domestic Facilities (FDA) Background: In 2004, FDA published a report on pharmaceutical quality for the 21st century t... FDA -20-RFQ- 1228728 Title: Quality Management Maturity Assessments At Up To Nine Domestic Facilities (FDA) Background: In 2004, FDA published a report on pharmaceutical quality for the 21st century that laid out the following vision: “a maximally efficient, agile, flexible manufacturing sector that reliably produced high-quality drug products without extensive regulatory oversight.” While we have made progress towards this vision, more remains to be done. Current Good Manufacturing Practices (CGMPs) establish a minimum standard for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Manufacturers that have a strong commitment to quality go beyond the minimum standards to implement enhanced quality management systems that enable sustainable compliance. Although CGMPs provide the foundation for such systems, the existing regulatory framework does not measure the capacity of a site to assure ongoing quality supply. The capacity for robust quality assurance is determined by maturity of the quality management system. Fully realizing the 21st century pharmaceutical quality vision requires a transparent method of evaluating and communicating quality management maturity. When manufacturers demonstrate rigorous oversight, understanding, and control over their manufacturing processes, FDA can exercise a more flexible regulatory approach, which should lead toward the goal of “high-quality drug products without extensive regulatory oversight” while also encouraging continual improvement of manufacturing processes. To provide adequate incentive for sites and firms to invest in quality management maturity to reduce the risk of drug shortages, it is important that purchasers and consumers accurately distinguish the quality management maturity of sites and firms manufacturing the products they buy. Objectives: The objective of the order is to fund quality management maturity assessments at up to nine domestic facilities (unique FEI) that are currently manufacturing drug product for the American public in the United States, as well as train a group of up to 10 FDA staff in conducting assessments. Funding the assessments will enhance CDER’s ability in developing a rating system to measure and rate quality management maturity based on specific objective indicators to this sector of the pharmaceutical industry. Please see question due date and submittal dates in the RFQ 1228723. Evaluation Criteria is included in the RFQ. Contact: Sharon Masciana at Sharon.Masciana@fda.hhs.gov