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…
