VGP
Designated Representative
Final Approval Authority & NABP/DSCSA Compliance
- Grant final approval on all new and revised Warehouse SOPs
- Verify all trading partners are DSCSA-authorized (ATP) before any receipt is accepted
- Ensure all warehouse personnel meet NABP qualification and training standards
- Oversee DSCSA compliance across all product receipts, transfers, and traceability records
- Escalate all regulatory findings, diversion suspicions, and CS incidents to management immediately
23 Active SOPs (SOP-WH-000 → SOP-WH-022) · NABP DDA/VAWD · 21 CFR Part 205 · DSCSA
VGP
Warehouse Manager
Operations Lead — Receiving, Storage, Shipping & Document Control
- Own all warehouse/distribution operations from receiving dock to outbound shipment
- Maintain SOP Master Index (SOP-WH-000) and all controlled-document records
- Oversee FEFO stock rotation, DSCSA T3 capture, and cold-chain integrity daily
- Authorize or escalate disposition of all quarantined, damaged, or suspect product with QA
- Assign role-based training curricula and verify competency before independent work
- Conduct self-inspection and management review per SOP-WH-016 / SOP-WH-019
- Post EOD warehouse report covering receiving, storage flags, and shipping status
VGP
Quality Assurance (QA)
Regulatory Accuracy & Product Disposition
- Review all SOPs for regulatory accuracy and NABP/DSCSA compliance before approval
- Approve all disposition decisions for quarantined, damaged, excursion, or suspect product
- Audit training records during every self-inspection cycle (SOP-WH-016)
- Confirm retraining completion before any revised SOP Effective Date
- Approve change controls and verify implementation across all affected procedures
- Escalate unresolved CAPAs and repeat deviations to the Designated Representative
VGP
Receiving Clerk
Inbound Verification — T3, Cold-Chain & Inspection
- Perform dock checks — verify carrier, PO/ASN, and shipment integrity before unloading
- Capture and verify DSCSA T3 data (TI/TH/TS) for every prescription product receipt
- Record arrival temperature for all cold-chain shipments before moving to storage
- Inspect all product for damage, counterfeit signs, broken seals, and mislabeling
- Quarantine and label any nonconforming, suspect, or excursion product immediately
- Never accept product from unverified or unlicensed trading partners — escalate to Designated Rep
VGP
Warehouse Associate
Storage, FEFO Rotation & Order Fulfillment
- Put away all received product under correct storage class (ambient / refrigerated / frozen)
- Rotate all stock FEFO — earliest expiry ships first, FIFO as tiebreaker
- Store all product off the floor on pallets or racks; maintain clear aisles and egress
- Pick, pack, and ship orders per SOP-WH-007 — verify item, quantity, lot, and expiry before sealing
- Report any damage, expired stock, or environmental concerns to Warehouse Manager immediately
- Maintain cleanliness and pest-prevention per SOP-WH-013 in all storage areas
VGP
Security / CS Custodian
Controlled-Substance Vault & Facility Security
- Control all access to and perpetual inventory of the Schedule II (C-II) vault
- Verify and log every controlled-substance receipt, pick, and transfer
- Enforce facility security and access-control protocols per SOP-WH-012 / SOP-WH-022
- Monitor for unauthorized entry, diversion signs, and security breaches — escalate immediately
- Support DSCSA suspect/illegitimate product quarantine and reporting per SOP-WH-011
- Maintain security logs retrievable for DEA, NABP, and state board inspection