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.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH Q10ICH Q12EU GMP Chapter 1
DOCUMENT TYPE
Record
LAST UPDATED
January 2025
PURPOSE

The record that captures a proposed change, assesses what it would affect, and routes it for approval before anything is done. The value of change control lies almost entirely in the impact assessment: a change approved without one is an unrecorded risk, and the most common inspection finding in this area is an implementation that preceded — or outgrew — its approval.

What's Inside

✓Change request identification, initiator, and the date the change was proposed
✓Description and justification, including the option of not changing and why it was rejected
✓Impact assessment across product quality, validated state, analytical methods, documentation, training, and supply
✓Regulatory reportability evaluation — whether the change affects a filing, and in which markets
✓Risk evaluation and categorisation that determines the approval route and the verification required
✓Implementation plan with tasks, owners, sequence, and the verification that each task achieved its purpose
✓Pre-implementation approvals and the post-implementation review that confirms the change did what it was approved to do

How to Use It

1Describe the change in terms of what will physically or procedurally differ afterwards, not in terms of the intended benefit
2Assess impact across every affected area, and record the areas you considered and ruled out as well as those affected
3Evaluate regulatory reportability per market; a change that is minor in one jurisdiction may be reportable in another
4Categorise by risk and let the category determine the approval route, rather than routing everything identically
5Approve before implementation — a retrospective approval is a deviation, and should be recorded as one
6Run the post-implementation review against the stated purpose, and close the change only when the verification supports it
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 requires a change management system that evaluates, approves, and implements changes with appropriate scientific and risk-based assessment, and EU GMP Chapter 1 requires changes that may affect product quality to be formally requested, documented, and accepted. ICH Q12 frames post-approval change categorisation and the tools that support it. Whether a given change is reportable in a given market is a regulatory determination the organisation makes with its regulatory affairs function; this template records the assessment, it does not make it.

MAPPED STANDARDS
ICH Q10ICH Q12EU GMP Chapter 1
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