Change Effectiveness Review Specification

This specification defines the Quality Unit–approved governance requirements for post-implementation review of GMP-impacting changes to confirm that intended objectives were achieved without adverse impact to product quality, compliance, or data integrity.

Specification Type:
Authoritative Quality Control specification defining change effectiveness review governance and decision authority. This document does not define review checklists, timelines, or monitoring tools.

1. Purpose

To establish Quality Unit–approved governance requirements ensuring that GMP-impacting changes are evaluated after implementation to verify effectiveness, confirm risk mitigation, and identify unintended outcomes.

2. Scope

This specification applies to all GMP-impacting changes subject to change control, including changes to materials, processes, analytical methods, equipment, facilities, systems, documents, and quality controls.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Production (PROD)
Packaging (PKG)
Laboratory Operations
Engineering & Facilities
Information Technology (IT)

3. Ownership & Governance

Owner: Quality Control (Quality Unit)
Approver: Quality Control Operations (QCO)
Change Control: Quality Management System (QMS)
Requirement Authority: QC-REQ-IDX
QC-REQ-IDX Reference: QC-CHG-004

Change effectiveness review requirements defined in this specification shall not be omitted, abbreviated, or informally applied outside approved QMS change control.

4. Change Effectiveness Review Requirements

Review Element	Requirement	Applicability
Objective Verification	Post-implementation review shall verify that change objectives and intended outcomes were achieved.	All GMP changes
Risk Mitigation Confirmation	Identified risks and mitigation measures shall be reviewed to confirm effectiveness.	Moderate to high-risk changes
Adverse Impact Assessment	Reviews shall assess for unintended adverse effects on quality, compliance, data integrity, or operations.	All GMP changes
Data-Based Evaluation	Effectiveness reviews shall be supported by appropriate data, trending, or performance indicators.	All applicable changes
Quality Unit Review	Effectiveness review conclusions shall be reviewed and approved by the Quality Unit.	All GMP changes

Effectiveness review timing and depth shall be proportionate to change impact and risk.

5. Decision Logic

Changes demonstrating effective outcomes may be closed.
Ineffective changes require additional action, modification, or escalation through change control.
Identified adverse impacts require evaluation and potential corrective action.
Final determinations regarding change effectiveness reside with the Quality Unit.

6. Escalation Requirements

Quality Assurance must escalate to Quality Control or QCO when any of the following occur:

Change objectives are not achieved
New or increased risks are identified post-implementation
Unexpected quality or compliance issues emerge
Disagreement regarding effectiveness conclusions

7. Records & Evidence

Records supporting compliance with this specification include, but are not limited to:

Change effectiveness review records
Performance and trending data
Quality Unit review and approval documentation
Follow-up actions and outcomes

This specification defines change effectiveness review governance and decision authority only. Review tools, monitoring methods, and execution steps are defined in separate controlled documents and shall not redefine the requirements herein.