FDA officials impart lessons learned from quality management maturity pilots

Regulatory NewsRegulatory News | 19 January 2023 |  By 

The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal.
These pilots “afforded FDA the opportunity to learn important lessons about the establishment of a QMM assessment process, scoring approach, assessor behaviors, and perceptions of the assessment questions, reports, and ratings.” The twelve FDA officials who authored the article said the lessons learned from the study will inform the development of a QMM program.
FDA launched the pilots in 2020 to assess the QMM of drug manufacturing establishments; one pilot program characterized the QMM for finished dosage forms for domestic manufacturers of prescription and OTC drug products, while another looked at QMM for foreign sites that produce active pharmaceutical ingredient (APIs) used in products marketed in the US. (RELATED: CDER launches quality management maturity pilots for APIs and finished dosage forms, Regulatory Focus 16 October 2020).
In terms of the assessment process, one of the lessons learned was to brief pilot participants ahead of the actual assessments, and to send an introduction packet or host a pre-meeting to learn what to expect of the assessment process.
“Advance engagement was valuable because the QMM assessment are significantly different from regulatory inspections with which establishments are familiar,” the officials wrote. Establishments also “found it helpful to have concrete examples of the types of documents that could substantiate the QMM ratings.”
Another learning is that some questions are best answered by corporate leaders who have responsibility across multiple establishments while others are best answered by establishment personnel. For this reason, “elements within the practice areas need to be grouped appropriately to enable participants to plan to have the necessary staff available when their input is needed.” 
In the area of scoring, assessors encountered challenges when using the scoring rubric, and recommended that a simplified scoring rubric would work best. “Unnecessary complexity in the level descriptions and the rubric may lead to subjectivity in scoring,” they wrote. “Redundant topics within or between practice areas may reduce the accuracy of scoring if these topics are accounted for more than once. A simplified rubric would increase the likelihood that the scores accurately reflect the maturity of each unique practice area.”
This feedback builds on earlier comments the agency received at a two-day workshop on QMM held in 2022. FDA reported that “the overall sentiment on the QMM program has been positive. For example, 99% of over 400 stakeholders polled at the 2022 CDER QMM Workshop believed that purchase of drug products or APIs, should ‘consider the QMM of the facility that manufactures them.”
Some future considerations include whether QMM assessments would be best executed by FDA or a third-party. Another area to be ironed out is whether assessments will be conducted virtually, on-site or via a hybrid approach.
FDA has been developing a QMM program since 2019 when an interagency task force proposed the development of a measure and rate the QMM of drug manufacturing facilities based on objective indicators to tackle the root cause and potential solutions for drug shortages, and 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 AAPS Journal


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