News Brief: FDA/CDER Accepting QMM Prototype Assessment Requests Until June 9

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) announced an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM).

CDER implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process to help enable consistent and meaningful assessment of participating establishments' quality management practices and to provide useful feedback to participants.

CDER will consider the following establishment characteristics when identifying potential participants for the program:

• The potential participant is an establishment as defined in 21 CFR 207.1 that registers with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and manufactures, prepares, propagates, compounds, or processes drugs, or APIs used in such drugs, subject to approval or licensure under section 505 of the FD&C Act or section 351 of the Public Health Service Act, or that are marketed pursuant to section 505G of the FD&C Act without an approved application under section 505 of the FD&C Act (often referred to as over-the-counter (OTC) monograph drug products).
• The establishment has received at least one human drug surveillance inspection.
• The current inspection classification for the establishment at the time of the request to participate is No Action Indicated or Voluntary Action Indicated.
• The establishment manufactures, prepares, propagates, compounds, or processes at least one CDER-regulated drug (API or finished drug product) that is currently in commercial distribution in the United States.
• The establishment is willing to participate in an onsite or hybrid assessment.

Prospective participants have until June 9, 2025, to submit requests to participate.

The notice, which includes contact information, is available here: Federal Register: Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program