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Zdrowie i gospodarka · 16.10.2020

Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement

The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing its Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF Pilot Program) for domestic drug product manufacturers of prescription and over-the-counter (OTC) drug products. The purpose of the QMM FDF Pilot Program is to gain insight from third-party assessments of a manufacturer'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 manufacturers. Manufacturers that choose to disclose their facility ratings could benefit from a competitive advantage, as knowledge of QMM ratings would enable health systems and other purchasers and payers of medications to differentiate among drug manufacturers. This notice invites manufacturers that are interested in participating in the QMM FDF Pilot Program to submit a request to participate.

Source: Federal Register — Food and Drug AdministrationOpen original release →