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RECORDREFERENCE OUTLINE
Change Control Request Form
Change control request capturing description, quality/validation/regulatory impact, risk categorisation, and approval before implementation. Aligned to ICH Q10 and ICH Q12.
REGULATIONS MAPPED
ICH Q10ICH Q12EU GMP Chapter 1
DOCUMENT TYPE
RecordLAST UPDATED
January 2025PURPOSE
A change control request that captures the proposed change, assesses its quality and regulatory impact, and routes it for risk-based approval before implementation.
What's Inside
✓Change description and justification
✓Impact assessment (product, process, validation, regulatory)
✓Risk evaluation and categorisation
✓Implementation and verification actions
✓Approval and post-implementation review
How to Use It
1Describe the change and the reason for it
2Assess impact across quality, validation, and filings
3Categorise the change by risk and regulatory reportability
4List implementation and verification tasks with owners
5Approve before implementation; review effectiveness after
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
1Change Request Identification
2Description and Justification
› Current state› Proposed change› Justification
3Impact Assessment
4Risk and Regulatory Reportability Evaluation
5Implementation Plan and Verification
6Approvals (Pre-Implementation)
7Post-Implementation Review and Closure
REGULATORY CONTEXT
ICH Q10 and EU GMP Chapter 1 require a formal change management system, and ICH Q12 frames post-approval change categories. This template documents impact and approval before any change is made.