Introduction:
Monthly Review Meetings (MRMs) are a cornerstone of an effective Quality Management System (QMS) within pharmaceutical manufacturing and other GMP-regulated environments. These structured meetings serve as a formal platform for cross-functional teams to review critical quality metrics, discuss ongoing issues, monitor the progress of corrective and preventive actions (CAPAs), and evaluate trends in deviations, complaints, change controls, and other compliance elements. Their purpose is to ensure informed decision-making, timely escalation of risks, and continuous improvement across operations.
Failure to conduct MRMs as scheduled, or conducting them ineffectively, poses significant risks. These include delayed detection of recurring quality issues, inadequate closure of investigations, missed opportunities for proactive improvement, and non-compliance with internal procedures or regulatory expectations. Furthermore, the absence of MRM activity can contribute to weak documentation practices, siloed decision-making, and diminished visibility for senior management over site performance and risks.
This risk assessment aims to systematically evaluate the consequences of not performing MRMs through the lens of people, processes, systems, and environment. It identifies potential failure modes, assesses their impact on product quality, patient safety, and regulatory compliance, and proposes actionable mitigation strategies. The goal is to ensure the reliability, continuity, and effectiveness of the MRM process as an integral part of site governance and pharmaceutical quality systems.