Full Cycle Services
FDA engaged Shabas through a competitive selection process as a prime contractor to lead the QMM Pilot for API Manufacturers (non-US). Eight API manufacturers from South America, Europe and Asia volunteered for this initiative. Under FDA’s guidance, Shabas conceptualized, developed and administered a QMM Assessment tool specifically designed for facilitated assessment of the API Manufacturers.
- Being unique, the QMM Assessment tool for the API Manufacturers had to be designed from ground-up to meet FDA’s requirement to gauge a manufacturing site’s ability to produce quality products consistently and reliably.
- The Shabas team developed an innovative assessment framework and a detailed analytical tool by leveraging insights from pharma and other industries that encompassed FDA-suggested practice areas and topics.
- The tool was administered virtually to the participating sites (with FDA as a silent observer) via facilitated assessment and results communicated to them (including cross-site benchmarking) using automated data analysis and creative reporting mechanisms.
- Shabas facilitated assessments using this comprehensive QMM Assessment tool was well received by the pilot participants and was a factor in their positive views of the QMM program.