Validation & Requalification Governance Specification

This specification defines the Quality Unit–approved governance requirements governing validation, verification, and requalification activities required following GMP-impacting changes.

Specification Type:
Authoritative Quality Control specification defining validation and requalification governance and decision authority. This document does not define validation protocols, execution steps, or test methods.

1. Purpose

To establish Quality Unit–approved governance requirements ensuring that changes impacting GMP systems, processes, or controls are supported by appropriate validation, verification, or requalification evidence prior to routine use.

2. Scope

This specification applies to all GMP-impacting changes that may affect validated systems, qualified equipment, controlled processes, analytical methods, utilities, or facilities.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Laboratory Operations
Production (PROD)
Packaging (PKG)
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-003

Validation and requalification governance requirements defined in this specification shall not be waived, reduced, or informally applied outside approved QMS change control.

4. Validation & Requalification Governance Requirements

Governance Element	Requirement	Applicability
Trigger Identification	Changes shall be evaluated to determine whether validation, verification, or requalification is required.	All GMP changes
Risk-Based Scope	The extent of validation or requalification shall be proportionate to the assessed risk and impact of the change.	All applicable changes
Pre-Use Completion	Required validation or requalification activities shall be completed and approved prior to routine GMP use.	All validated systems and processes
Quality Unit Approval	Validation and requalification outcomes shall be reviewed and approved by the Quality Unit.	All validation activities
Ongoing State Control	Validated states shall be maintained through controlled operation and periodic review.	All validated systems

Validation governance applies equally to new implementations, modifications, upgrades, and requalification activities.

5. Decision Logic

Systems and processes supported by approved validation evidence may be released for routine GMP use.
Incomplete or failed validation prohibits routine GMP use.
Validation scope may be adjusted only through approved change control.
Final determinations regarding validation adequacy reside with the Quality Unit.

6. Escalation Requirements

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

Validation or requalification failures
Disagreement regarding validation scope or adequacy
Pressure to release systems prior to validation completion
Unexpected outcomes during validation activities

7. Records & Evidence

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

Validation plans and protocols
Validation and requalification reports
Quality Unit approvals of validation outcomes
Change control records linking validation requirements

This specification defines validation and requalification governance and decision authority only. Validation execution procedures, test methods, and acceptance criteria are defined in separate controlled documents and shall not redefine the requirements herein.