Temperature-Controlled Storage Specification
This specification defines the Quality Unit–approved environmental acceptance criteria and decision requirements for GMP-designated temperature-controlled storage conditions.
Authoritative Quality Control specification defining acceptance criteria and decision logic. This document does not define monitoring methods, alarm settings, or operational procedures.
1. Purpose
To establish Quality Unit–approved acceptance criteria for temperature-controlled storage environments, ensuring that materials and products requiring controlled temperatures are stored under conditions that preserve identity, strength, purity, composition, and stability.
2. Scope
This specification applies to all GMP-designated storage locations used for refrigerated, frozen, or otherwise temperature-controlled storage of materials, components, in-process materials, finished products, or retained samples.
Applicable Business Domains include:
- Warehouse Operations (WH)
- Quality Assurance (QA)
- Quality Control (QC)
- Production (PROD), when temperature-controlled storage is utilized
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-004
Acceptance criteria and decision thresholds defined in this specification shall not be modified outside approved QMS change control.
4. Temperature Acceptance Criteria
| Storage Classification | Acceptance Criteria | Applicability |
|---|---|---|
| Refrigerated Storage | 2°C – 8°C | Materials or products labeled or approved for refrigerated storage |
| Frozen Storage | ≤ −20°C | Materials or products requiring frozen storage conditions |
| Other Controlled Conditions | As defined by approved product, material, or stability specifications | Specialty or non-standard temperature-controlled storage |
Where product- or material-specific storage requirements are more restrictive than the criteria listed above, the more restrictive criteria shall apply.
5. Decision Logic
- Storage conditions maintained within approved temperature ranges are considered conforming.
- Single, brief temperature excursions require documented review by Quality Assurance.
- Extended, repeated, or significant temperature excursions require escalation to Quality Control for impact assessment and disposition decision.
- Final disposition decisions are made by the Quality Unit based on reviewed evidence, duration of excursion, and product stability considerations.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following conditions occur:
- Temperature conditions exceed approved acceptance criteria
- Repeated or trending excursions are identified
- Temperature control failures occur during storage or handling
- Potential impact to product quality, stability, or shelf life is identified
- Monitoring system reliability or data integrity concerns are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Temperature monitoring records and trend reports
- Excursion reviews, investigations, and corrective actions
- Quality Assurance assessments and escalation documentation
- Quality Unit disposition decisions and supporting rationale