Warehouse Environmental Control Specification
This specification defines the Quality Unit–approved environmental acceptance criteria and decision requirements for warehouse storage areas used for GMP materials and products.
Authoritative Quality Control specification defining acceptance criteria and decision logic. This document does not define execution steps or procedures.
1. Purpose
To establish Quality Unit–approved environmental acceptance criteria for temperature and humidity conditions within warehouse storage areas, ensuring that stored materials and products remain suitable for their intended use throughout storage and handling.
2. Scope
This specification applies to all GMP-designated warehouse storage areas where raw materials, components, in-process materials, finished products, or retained samples are stored.
Applicable Business Domains include:
- Warehouse Operations (WH)
- Quality Assurance (QA)
- Production (PROD), when materials are staged in warehouse-controlled areas
- Packaging (PKG), when materials are staged in warehouse-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-001
No environmental acceptance criteria or decision thresholds defined in this specification may be modified outside approved QMS change control.
4. Environmental Acceptance Criteria
| Parameter | Acceptance Criteria | Applicability |
|---|---|---|
| Temperature | 15°C – 25°C | All GMP-designated warehouse storage areas |
| Relative Humidity | ≤ 60% RH | All GMP-designated warehouse storage areas unless otherwise specified |
5. Decision Logic
- Environmental conditions within acceptance criteria are considered conforming.
- Single excursions outside acceptance criteria require documented review by Quality Assurance.
- Repeated excursions, extended duration excursions, or excursions impacting temperature- or humidity-sensitive materials require escalation to Quality Control for disposition decision.
- Final disposition decisions are made by the Quality Unit based on reviewed evidence and risk assessment.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Environmental conditions exceed acceptance criteria beyond defined tolerances
- Recurring or trending excursions are identified
- Excursions potentially impact product quality or stability
- Data integrity or monitoring reliability concerns are identified