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PROTOCOLREFERENCE OUTLINE
Internal Audit Program & Checklist
Risk-based self-inspection program with an annual schedule, area-by-area checklists, and finding-to-CAPA tracking. Maps to ICH Q10 self-inspection and 21 CFR 820.22.
REGULATIONS MAPPED
ICH Q1021 CFR Part 820
DOCUMENT TYPE
ProtocolLAST UPDATED
January 2025PURPOSE
A risk-based internal (self-inspection) audit program and checklist that plans the audit schedule, structures each audit by GMP area, and tracks findings to closure.
What's Inside
✓Annual risk-based audit schedule
✓Area-by-area audit checklists
✓Objective evidence and finding capture
✓Finding classification and CAPA linkage
✓Audit report and management summary
How to Use It
1Build the schedule from area risk and prior findings
2Use the area checklists to structure each audit
3Record objective evidence for every observation
4Classify findings and assign CAPA owners
5Summarise for management review
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
1Audit Program Scope and Objectives
2Risk-Based Annual Schedule
3Auditor Assignment and Independence
4Area Audit Checklist
5Findings Log and Classification
6CAPA Linkage and Tracking
7Audit Report
8Management Review Summary
REGULATORY CONTEXT
ICH Q10 and 21 CFR 820.22 require internal audits / self-inspection and management awareness of the results. This template makes the program risk-based and traceable to closure.