| # | SOP | WIN | AA Doc ID | Frequency | Description (Purpose, Scope, Control Intent & Auditor Focus) |
|---|---|---|---|---|---|
| Material Flow | |||||
| 1 | SOP-WH-RECV | WIN-WH-RECV-VERIFY | AA-WH-RECV-VERIFY | Per Receipt |
Purpose: Verify identity, packaging integrity, quantity,
delivery vehicle condition, and accompanying documentation of inbound materials. Control Intent: Prevent unverified or compromised materials from entering GMP control. |
| 2 | SOP-WH-STATUS | WIN-WH-STATUS-MAINTAIN | AA-WH-STATUS-MAINTAIN | Ongoing |
Purpose: Maintain traceable history of material status changes. Control Intent: Prevent unauthorized use or release. |
| 3 | SOP-WH-RACKMAP | WIN-WH-RACKMAP-CONTROL | AA-WH-RACKMAP-CONTROL | Change-Driven |
Purpose: Define approved rack locations by material status. Control Intent: Prevent mix-ups and enforce segregation. |
| 4 | SOP-WH-STORAGE | WIN-WH-STORAGE-ENV-MONITOR | AA-WH-STORAGE-ENV-MONITOR | Routine / Continuous |
Purpose: Monitor warehouse environmental conditions applicable
to material storage. Control Intent: Detect excursions that may impact material quality and trigger QA escalation. Governance: QA-defined limits; Warehouse-executed monitoring. |
| 5 | SOP-WH-STORAGE | WIN-WH-MATERIAL-SEGREGATION | AA-WH-MATERIAL-SEGREGATION | Continuous |
Purpose: Enforce physical and system-based segregation of materials
by status. Control Intent: Prevent mix-ups and unauthorized use. |
| 6 | SOP-WH-STORAGE | WIN-WH-EXCEPTION-ESCALATION | AA-WH-EXCEPTION-ESCALATION | Event-Driven |
Purpose: Escalate warehouse-identified quality concerns through
the Quality Management System. Control Intent: Ensure timely QA review, investigation, and disposition under QA authority. |
| 7 | SOP-WH-TRANSFERS | WIN-WH-TRANSFERS-RECORD | AA-WH-TRANSFERS-RECORD | Per Transfer |
Purpose: Document controlled movement between locations. Control Intent: Prevent unauthorized status changes. |
| 8 | SOP-WH-SHIP | WIN-WH-SHIP-RELEASE | AA-WH-SHIP-RELEASE | Per Shipment |
Purpose: Verify shipment accuracy and release authorization. Control Intent: Prevent incorrect distribution. |
| Inventory Controls | |||||
| 9 | SOP-WH-INVT | WIN-WH-INVT-VERIFY | AA-WH-INVT-VERIFY | Cycle / Physical | Purpose: Verify inventory accuracy and reconciliation. |
| 10 | SOP-WH-INVT | WIN-WH-INVT-ADJUST | AA-WH-INVT-ADJUST | As Needed | Purpose: Document authorized inventory adjustments. |
QC-owned IPC receiving checks may be executed by qualified Warehouse personnel under delegated authority. Acceptance criteria and oversight remain governed by QA.
Returned Product Handling:
Returned materials do not generate standalone Warehouse-owned AAs.
Warehouse evidence is captured through existing status, inventory, location,
and movement records. Disposition remains QA-governed.