cGMP Part 111 compliant holding operations with GDP principles: environmental controls, lot traceability, FEFO inventory management, and real-time WMS.
cGMP Part 111 holding operations require controlled conditions. We exceed standards with continuous monitoring and documented controls.
Comprehensive zoning with continuous data logging
Real-time environmental oversight
Rigorous sanitation protocols per cGMP Part 111
FEFO methodology reduces expiry risk. Lot/batch traceability ensures recall readiness.
Full chain of custody from receipt to shipment
Physical separation to prevent mix-ups
Intelligent picking to minimize waste
Continuous accuracy verification
Real-time stock visibility, automated reorder points, ASN/EDI, API exports, and KPI dashboards
cGMP Part 111 emphasizes documented controls. We maintain receiving inspections, sampling plans, deviation/CAPA logs, and recall simulation readiness.
Every inbound shipment is inspected before acceptance
Statistical sampling aligned with cGMP Part 111
Documented investigation and corrective actions
Quarterly mock recalls to test traceability
Kitting, relabeling, FBA prep, returns management—all with documented quality controls
Assemble multi-SKU sets for promotions or retail
cGMP-compliant label changes (batch/lot, corrective)
FNSKU labeling, poly-bagging, carton requirements
Inspection, quarantine, and disposition (resell/destroy/rework)
| Performance Metric | Target SLA | Current Performance |
|---|---|---|
| Pick Accuracy | 99.9% | 99.95% |
| Dock-to-Stock Time | < 4 hours | 2.5 hours |
| Order Processing | < 24 hours | 18 hours |
| On-Time Ship Rate | 98% | 98.7% |
| Inventory Accuracy | 99.5% | 99.9% |
| Damage Rate | < 0.1% | 0.03% |