Change Control Governance Specification

This specification defines the Quality Unit–approved governance requirements for the identification, evaluation, approval, implementation, and oversight of changes that may impact GMP products, processes, systems, facilities, or quality controls.

Specification Type:
Authoritative Quality Control specification defining change control governance and decision authority. This document does not define change request forms, system workflows, or implementation procedures.

1. Purpose

To establish Quality Unit–approved governance requirements ensuring that GMP-impacting changes are systematically assessed, approved, implemented, and reviewed in a controlled manner that protects product quality, regulatory compliance, and data integrity.

2. Scope

This specification applies to all planned or unplanned changes that may impact GMP products, materials, processes, analytical methods, equipment, facilities, systems, documents, or quality controls.

Applicable Business Domains include:

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

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-001

Change control governance requirements defined in this specification shall not be bypassed, informally applied, or modified outside approved QMS change control.

4. Change Control Governance Requirements

Governance Element	Requirement	Applicability
Change Identification	GMP-impacting changes shall be formally identified and documented prior to implementation.	All GMP changes
Pre-Approval Requirement	Changes shall not be implemented without prior Quality Unit approval, except under approved emergency governance.	All GMP changes
Risk-Based Evaluation	Changes shall be evaluated for potential impact to product quality, regulatory commitments, data integrity, and patient or consumer safety.	All GMP changes
Implementation Control	Approved changes shall be implemented in a controlled and traceable manner consistent with their approval conditions.	Approved changes
Post-Implementation Oversight	Changes shall be reviewed post-implementation to confirm effectiveness and absence of unintended adverse impact.	All GMP changes

Change control applies equally to improvements, corrections, replacements, upgrades, and emergency modifications.

5. Decision Logic

Changes meeting governance requirements may be approved and implemented.
Changes lacking sufficient impact assessment shall not be approved.
Uncontrolled changes constitute a quality system failure.
Final determinations regarding change approval reside with the Quality Unit.

6. Escalation Requirements

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

Unapproved or undocumented GMP changes
Emergency changes without retrospective approval
Disagreement regarding change impact or classification
Changes resulting in quality or compliance concerns

7. Records & Evidence

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

Change requests and approvals
Impact and risk assessments
Implementation records
Post-implementation effectiveness reviews

This specification defines change control governance and decision authority only. Change request forms, workflow systems, and implementation procedures are defined in separate controlled documents and shall not redefine the requirements herein.