Evaluating the PDA Quality Culture Assessment Tool as a Foundation to Advance Quality Management Maturity

The U.S. Food and Drug Administration (FDA) introduced the Quality Management Maturity (QMM) initiative to promote quality practices in pharmaceutical manufacturing that extend beyond basic good manufacturing practices (GMP), as a response to the ongoing drug shortage crisis. As the FDA has yet to formalize a QMM assessment tool, this study evaluated the Parenteral Drug Association's (PDA) Quality Culture Assessment Tool (QCAT) as a potential surrogate framework. Using anonymized data from 58 life sciences companies, we assessed internal consistency and examined whether the QCAT constructs differentiated responses across organizational, regional, and manufacturing modalities characteristics. Four of five domains-Employee Ownership and Engagement, Continuous Improvement, Technical Excellence, and Communication & Collaboration-demonstrated acceptable internal consistency (Cronbach's α ≥ 0.70), whereas Leadership Commitment yielded a lower reliability coefficient (α = 0.49). Technical Excellence scores significantly differed by business function (p = 0.02), with higher ratings reported by innovator firms compared to contract manufacturing organizations (CMO). These findings suggest that the PDA QCAT offers a promising model for operationalizing QMM principles, although refinement may be needed to enhance measurement of leadership constructs.