The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing its Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API Pilot Program) for foreign facilities manufacturing active pharmaceutical ingredients (APIs), including facilities manufacturing drug substance intermediates used to produce APIs, that are used in FDA-regulated prescription and over-the-counter (OTC) drug products.
The purpose of the QMM API Pilot Program is to gain insight from third-party assessments of a facility’s quality management system to inform future development of an FDA rating system to characterize quality management maturity (QMM). Such a rating system would allow a cross-sectional comparison of facilities.
Facilities that choose to disclose their facility ratings to drug product manufacturers could benefit from a competitive advantage, as knowledge of QMM ratings would enable drug product manufacturers to differentiate among facilities when purchasing APIs. This notice invites foreign facilities that are interested in participating in the QMM API Pilot Program to submit a request to participate.
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FDA will accept requests to participate in the QMM API Pilot Program through November 30, 2020, and the QMM API Pilot Program will run through December 31, 2021. See This document is scheduled to be published in the Federal Register on 10/16/2020 and available online at federalregister.gov/d/2020-22977, and on govinfo.gov the “Participation” section for selection criteria and instructions on how to submit a request to participate.
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