Retained Sample Lifecycle Specification

This specification defines the Quality Unit–approved requirements governing the retention, storage, use, and disposition of retained samples throughout the product lifecycle.

Specification Type:
Authoritative Quality Control specification defining retained sample lifecycle governance and decision authority. This document does not define sampling techniques, storage procedures, or laboratory testing methods.

1. Purpose

To establish Quality Unit–approved requirements ensuring that retained samples are representative, protected, traceable, and available to support investigations, stability evaluations, complaints, and regulatory inquiries throughout the product lifecycle.

2. Scope

This specification applies to all GMP products requiring retained samples, including finished products, components where applicable, and stability or reserve samples maintained post-release.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Warehouse Operations (WH)
Laboratory Operations
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-STAB-002

Retained sample lifecycle requirements defined in this specification shall not be modified outside approved QMS change control.

4. Retained Sample Lifecycle Requirements

Lifecycle Element	Requirement	Applicability
Sample Representativeness	Retained samples shall be representative of the released lot or batch and suitable for their intended use.	All retained samples
Storage Conditions	Retained samples shall be stored under conditions appropriate to preserve sample integrity throughout the retention period.	All retained samples
Retention Period	Retained samples shall be maintained for a defined period aligned with regulatory, quality, and business requirements.	All retained samples
Access & Use Control	Use or removal of retained samples shall be controlled and documented to ensure traceability and integrity.	All retained sample usage
Disposition & Destruction	Retained samples shall be disposed of or destroyed only after completion of the approved retention period and Quality Unit approval.	End-of-life retained samples

Retained samples shall be managed to ensure they remain suitable to support quality evaluations and regulatory needs throughout their lifecycle.

5. Decision Logic

Retained samples maintained in accordance with this specification are considered suitable for quality and regulatory use.
Compromised or missing retained samples require evaluation and escalation.
Use of retained samples for investigations or testing shall be controlled and documented.
Final determinations regarding retained sample lifecycle management reside with the Quality Unit.

6. Escalation Requirements

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

Missing, damaged, or compromised retained samples
Inability to meet required retention periods
Unauthorized access or use of retained samples
Disputes regarding retained sample disposition

7. Records & Evidence

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

Retained sample inventories and tracking records
Storage condition monitoring records
Retained sample use and access logs
Quality Unit approvals for sample disposition or destruction

This specification defines retained sample lifecycle governance and decision authority only. Sampling execution, storage handling procedures, and laboratory testing practices are defined in separate controlled documents and shall not redefine the requirements herein.