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REPORTREFERENCE OUTLINE
Quality Management Review Pack
Management review pack assembling PQS performance metrics, deviation/CAPA/change status, and audit outcomes for leadership decisions. Structures the ICH Q10 / 21 CFR 820.20 review.
REGULATIONS MAPPED
ICH Q1021 CFR Part 820
DOCUMENT TYPE
ReportLAST UPDATED
January 2025PURPOSE
A quality management review pack that assembles the pharmaceutical quality system’s health metrics for leadership — so the PQS is actively governed, not just documented.
What's Inside
✓PQS performance metrics and trends
✓Deviation, CAPA, and change status
✓Complaint, recall, and audit summary
✓Product quality and process performance
✓Actions, decisions, and resource needs
How to Use It
1Aggregate PQS metrics for the review period
2Highlight trends, escalations, and overdue actions
3Review product quality and process performance
4Record decisions, actions, and resource commitments
5Track prior-review actions to closure
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Review Scope, Period, and Attendees
2Status of Actions from Prior Reviews
3PQS Performance Metrics and KPIs
4Deviations, CAPAs, and Change Control
5Complaints, Recalls, and Audit Outcomes
6Product Quality and Process Performance
7Decisions, Actions, and Resources
8Sign-off
REGULATORY CONTEXT
ICH Q10 and 21 CFR 820.20 require periodic management review of the quality system with documented actions. This pack structures the inputs and captures the leadership decisions.