FDA seeks feedback on quality management maturity program
The US Food and Drug Administration (FDA) is asking for stakeholder input as it develops a voluntary quality management maturity program (QMM).The request for comments follows a November 2022 meeting of FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee where the agency sought to gauge academic and industry support for establishing a QMM program. Support for the program was affirmed with a 9-0 vote from the committee. FDA said that “during deliberations, committee members advised the Agency to continue to seek stakeholder input throughout the program's development.”
FDA first proposed a QMM program in 2019 when an interagency task force called for the development of a new system to measure and rate the QMM of drug manufacturing facilities to tackle the root cause and potential solutions for drug shortages. The proposal was further refined last year (RELATED: FDA Task Force Recommends Rating System for Drug Manufacturing Quality, Regulatory Focus 29 October 2019; FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus 7 April 2022).
The goals of the program are to create a “strong quality culture mindset,” to recognize those firms that have advanced QMM practices, target areas where QMM practices can be improved, and minimize risks to product availability.
Trained assessors would conduct the QMM assessments, either onsite or in a hybrid environment, over the course of two to five business days. The QMM assessment would cover five practice areas including management commitment to quality, business continuity, advanced pharmaceutical quality systems, technical excellence, and employee engagement and empowerment.
Within each practice area, the assessors would explore key elements to understand an establishment's QMM. Elements that could be covered include management review and resource management, supply planning and demand forecasting, data governance, effectiveness of the corrective action and preventive action process, and rewards and recognition.
FDA is seeking input in several areas, including what advantages manufacturers anticipate from participating in the voluntary QMM program, the types of drug products produced by various manufacturers, the benefits of participating, how the information from a QMM assessment could be used, and any unintended consequences or roadblocks from participating.
FDA is also asking what information QMM reports should include and if the reports should be made public. FDA said “the QMM assessment is designed to appraise an establishment's quality culture mindset, behaviors, and commitment to adopting best practices to effectively meet the needs of patients and consumers.” However, these assessments would not be used to evaluate compliance with current good manufacturing practice (CGMPs), the agency noted
The deadline for commenting is 14 December. Submit comments here.
FDA announcement
