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# Quality Management Maturity Dividing Industry: PDA
- URL: https://www.fdaweb.com/quality-management-maturity-dividing-industry-pda/
- Published: 2023-04-27T12:00:00.000Z
- Updated: 2026-09-14T18:28:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154319

A Parenteral Drug Association (PDA) online post says discussion with industry members demonstrates ongoing concerns about CDER’s Quality Management Maturity (QMM) program that was approved at an 11/2-11/3/22 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The [post](https://www.pda.org/pda-letter-portal/home/full-article/industry-remains-divided-on-quality-management-maturity-proposal?ref=fdaweb.com) says QMM is intended to incentivize investment in mature quality management practices.

PDA says its discussions with industry members yielded these suggested incentives for consideration:

- regulatory flexibility in the submission of post-approval changes;
- increased use of waivers for both pre-approval inspection and pre-licensure inspections or records requests instead of inspections;
- allowing companies with low QMM ratings to meet with FDA to address quality issues in real-time and leverage the agency’s expertise to help the sites solve quality issues before they lead to inadequate products being distributed to patients;
- adopting proactive interactions with drug manufacturers to address quality issues in real-time to assist FDA in resolving issues such as drug product recalls and drug shortages; and
- greenlighting FDA quality profile data for use by the HHS Centers for Medicare and Medicaid Services and Defense Department procurement offices.

Members of the industry, PDA says, also expressed concerns about:

- extra resources required by a company to administer the program and meet reporting requirements;
- FDA's inability to correctly interpret the data that would be collected, creating significant additional work as companies respond to questions;
- overflow of variability and subjectivity in audit programs used to assess QMM; and
- effectiveness of the program, which depends on multiple regulatory agencies recognizing the program and its rating system.