Outsourced Testing Governance Specification

This specification defines the Quality Unit–approved governance requirements for acceptance, control, and use of analytical results generated by external or contract laboratories in support of GMP decisions.

Specification Type:
Authoritative Quality Control specification defining outsourced testing governance and decision authority. This document does not define supplier audits, laboratory procedures, or contractual arrangements.

1. Purpose

To establish Quality Unit–approved requirements ensuring that analytical results generated by external laboratories are suitable, reliable, and appropriately governed prior to use in GMP acceptance, release, or disposition decisions.

2. Scope

This specification applies to all outsourced or contract laboratory testing performed in support of GMP-relevant analytical evaluations, including identity, purity, potency, safety, stability, and release testing.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Supply Chain / Procurement
External / Contract Laboratories

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-ANL-004

Outsourced testing governance requirements defined in this specification shall not be modified outside approved QMS change control.

4. Outsourced Testing Governance Requirements

Governance Element	Requirement	Applicability
Laboratory Qualification	External laboratories shall be qualified and approved by the Quality Unit prior to use for GMP-relevant testing.	All outsourced testing
Method Suitability	Analytical methods used by external laboratories shall be demonstrated to be suitable for their intended use.	All outsourced analytical methods
System & Instrument Suitability	External laboratory instruments and systems shall be suitable and appropriately controlled for GMP testing.	All outsourced analytical systems
Data Review & Acceptance	Analytical results generated by external laboratories shall be reviewed and accepted by the Quality Unit prior to use in GMP decisions.	All outsourced analytical results
Deviation & OOS Handling	Deviations, OOS results, or atypical findings from outsourced testing shall be governed under the site Quality Management System.	All outsourced testing exceptions

Outsourced analytical results shall not be used to support GMP acceptance or release decisions without documented Quality Unit review and approval.

5. Decision Logic

Analytical results from qualified external laboratories may be used to support GMP decisions following Quality Unit review.
Results generated under unapproved conditions shall not be accepted for GMP use.
Identified concerns regarding outsourced data reliability require escalation and evaluation prior to decision-making.
Final determinations regarding acceptance of outsourced analytical results reside with the Quality Unit.

6. Escalation Requirements

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

Use of unqualified or unapproved external laboratories
Concerns regarding outsourced method or system suitability
Outsourced OOS, deviations, or atypical results
Data integrity or documentation concerns involving external laboratories

7. Records & Evidence

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

External laboratory qualification and approval records
Outsourced analytical result reports
Quality Unit review and acceptance documentation
Deviation and investigation records related to outsourced testing

This specification defines outsourced testing governance and decision authority only. External laboratory procedures, audit execution, contractual terms, and operational practices are defined in separate controlled documents and shall not redefine the requirements herein.