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# CDER Starting 2 Quality Management System Pilots
- URL: https://www.fdaweb.com/cder-starting-2-quality-management-system-pilots/
- Published: 2020-10-15T12:00:00.000Z
- Updated: 2026-09-14T16:32:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147879

CDER says it is starting two new pilot programs to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an agency rating system. The Center says a rating system would characterize quality management maturity and incentivize investment in quality manufacturing.

The [Quality Management Maturity for Finished Dosage Forms Pilot Program](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDEwMTUuMjg3ODg4NDEiLCJ1cmwiOiJodHRwczovL3B1YmxpYy1pbnNwZWN0aW9uLmZlZGVyYWxyZWdpc3Rlci5nb3YvMjAyMC0yMjk3Ni5wZGY%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.FN9nNh9h4%5FN6jI4tlLeAy6CK6acjVatn1icj1CosXmo/s/1255718496/br/86913663914-l?ref=fdaweb.com) is for domestic drug product manufacturers of prescription and over-the-counter (OTC) drug products. The [Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDEwMTUuMjg3ODg4NDEiLCJ1cmwiOiJodHRwczovL3B1YmxpYy1pbnNwZWN0aW9uLmZlZGVyYWxyZWdpc3Rlci5nb3YvMjAyMC0yMjk3Ny5wZGY%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.%5F6LUBX4tYg08uk7kLD0vvi9%5FoeFTZMrJrFejvATIaZA/s/1255718496/br/86913663914-l?ref=fdaweb.com) is for foreign manufacturers of active pharmaceutical ingredients (APIs), including drug substance intermediates used to produce APIs, used in FDA-regulated prescription and OTC drug products.