Retained Sample Storage Specification
This specification defines the Quality Unit–approved environmental acceptance criteria and decision requirements for the storage of retained samples.
Authoritative Quality Control specification defining environmental acceptance criteria and decision logic. This document does not define sampling procedures, storage operations, or monitoring execution.
1. Purpose
To establish Quality Unit–approved environmental acceptance criteria for the storage of retained samples, ensuring that retained materials remain suitable for future examination, investigation, or regulatory review throughout their required retention period.
2. Scope
This specification applies to all GMP-designated storage areas used for retained samples of raw materials, components, in-process materials, finished products, and packaging components, unless otherwise specified by product- or material-specific requirements.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Warehouse Operations (WH)
- Production (PROD), when retained samples are stored in controlled areas
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-ENV-005
Environmental acceptance criteria and decision thresholds defined in this specification shall not be modified outside approved QMS change control.
4. Environmental Acceptance Criteria
| Parameter | Acceptance Criteria | Applicability |
|---|---|---|
| Temperature | 59°F – 77°F | Retained samples stored under controlled room temperature conditions, unless otherwise specified |
| Relative Humidity | ≤ 60% RH | Retained samples unless otherwise specified by product, material, or packaging requirements |
Where retained samples require refrigerated, frozen, or otherwise specialized storage conditions, the applicable approved temperature-controlled storage specification shall apply.
5. Decision Logic
- Retained samples stored within acceptance criteria are considered conforming.
- Single, brief excursions outside acceptance criteria require documented review by Quality Assurance.
- Extended, repeated, or significant excursions require escalation to Quality Control for assessment of retained sample suitability.
- Decisions regarding continued retention, replacement, or disposition of retained samples are made by the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Environmental conditions exceed acceptance criteria
- Recurring or trending excursions are identified
- Retained sample integrity may be compromised
- Monitoring reliability or data integrity concerns are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Environmental monitoring records for retained sample storage areas
- Excursion reviews, investigations, and corrective actions
- Quality Assurance assessments and escalation documentation
- Quality Unit decisions regarding retained sample disposition or replacement