WH – Warehousing Business Process
The Warehousing (WH) business process governs the receipt, storage, movement, and status-based segregation of materials and product to preserve identity, traceability, and suitability for downstream GMP activities.
Warehousing Operating Model
The Warehousing Operating Model below illustrates how materials and product are received, controlled, stored, and transferred while maintaining continuous status-based and physical segregation.
Received materials and components
Packaged finished goods
Approved receiving documentation
Receipt verification, labeling, and initial status assignment
Controlled storage under defined environmental and status conditions
Authorized movement, location control, and traceable handling
Ongoing verification of material and product status integrity
Status-controlled materials
Released or restricted inventory
Authorized transfer to MR, PKG, or Distribution
Warehousing maintains custody of sealed materials and packaged product and does not perform material exposure, readiness, or batch execution activities.
Process Interfaces & Boundaries
- Upstream: Procurement (PROC) and suppliers – delivery of authorized materials
- Downstream: Material Readiness (MR), Packaging (PKG), or Distribution – authorized inventory transfer
- Governance: QMS defines status, release, and segregation controls; Warehousing executes custody activities
Quality Control Requirements Executed by Warehouse
Warehouse is classified as a QC-Executing Domain. Warehouse activities execute defined Quality Control Requirements under the authority of Quality Control Operations (QCO) and in accordance with the Quality Control Requirements Index (QC-REQ-IDX).
- QC-ENV-001 – Warehouse Environmental Conditions: Warehouse maintains environmental controls necessary to preserve material integrity.
- QC-ENV-004 – Temperature-Controlled Storage: Warehouse ensures temperature-controlled materials are stored, monitored, and handled within defined limits.
- QC-ENV-005 – Retained Sample Storage: Warehouse maintains storage conditions for retained samples in accordance with defined requirements.
- QC-MAT-004 – Material Storage & Handling Condition: Warehouse controls storage, segregation, and handling practices to prevent mix-up, damage, or deterioration.
- QC-DISP-003 – Rejection & Quarantine Governance: Warehouse enforces physical and system-based controls for rejected, quarantined, or restricted materials.
Final disposition decisions remain under the authority defined within QC-DISP requirements. Warehouse enforces status control but does not independently alter disposition determinations.
Inventory discrepancies, damage, or status deviations identified during Warehousing activities are documented and escalated through the Quality Event process in accordance with the enterprise Quality System.