USA – FDA launches pilots targeting API, finished dosage QMM

Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).

The agency’s Center for Drug Evaluation and Research (CDER) is hoping to “gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system,” according to CDER’s announcement to industry of the new pilot programs.

One pilot program will characterize quality management maturity (QMM) for finished dosage forms from domestic manufacturers of prescription and over-the-counter (OTC) drug products. The second pilot will look at QMM for active pharmaceutical ingredients (APIs), including drug substance intermediates, from foreign manufacturers and destined for use in FDA-regulated prescription and OTC products…