Good Distribution Practice (GDP) – Storage, Transport, and Proof of Control Across the Supply Chain

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Storage & Transport Governance • QA/QP, Logistics, WMS, MES

Good Distribution Practice (GDP) comprises the controls that keep products fit for use as they move from release to the point of dispensing or sale. GDP translates product-specific requirements—identity, strength, purity, safety, usability, and labeling claims—into storage, handling, packaging, and transport rules that survive real-world logistics. It is the connective layer between Batch/Finished Goods Release and the moment a customer signs for goods: qualifying warehouses and carriers, mapping lanes and conditions, stabilizing temperatures and humidity, verifying seals and counts, maintaining chain-of-identity via EPCIS or equivalent event histories, and retaining evidence that what was shipped matched what was approved. GDP is not a “paper on the dock” concept; it is a set of operational controls that the system enforces in every pick, pack, load, and hand-off.

“Quality does not end at the warehouse door. GDP is the discipline of making every mile between release and receipt as controlled and as auditable as the batch record itself.”

1) What GDP Is

GDP is the application of quality system thinking to distribution. It begins at the point where product is dispositioned for sale or further supply and ends when custody passes to the next qualified party. Between these points, GDP demands three kinds of control. First, condition control: products are kept within their validated environmental ranges (e.g., 2–8°C, CRT, humidity limits), protected from contamination/cross-contamination, light, and physical abuse, and shielded from substitution and tampering. Second, identity and documentation control: every unit is traceable by lot/UDI/SSCC, picks are confirmed from the right locations with the right expiries (see FIFO and FEFO counterparts), labels match the approved masters, and shipping documentation is complete and legible. Third, capability control: warehouses, 3PLs, carriers, and packaging methods are qualified against the product’s risk profile, including thermal performance, shock/vibration tolerance, and security posture. GDP does not insist that every shipment is identical; it insists that every deviation from the ideal is understood, justified, controlled, and recorded.

2) Regulatory Anchors & Scope

GDP is expressed across multiple predicate regimes. For medicines and biologics, distribution requirements flow from marketing authorization commitments and GMP expectations (e.g., storage and transport under conditions that maintain quality) and are inspected as part of the quality system. For devices, chain-of-distribution and DHR traceability intersect GDP through UDI, labeling, and handling. In food/supplements, the Food Safety Plan (FSP) may designate distribution controls as preventive controls; allergen segregation and cross-contamination control extend to warehouses and carriers. Regardless of sector, when distribution records are electronic, Part 11/Annex 11 expectations apply: unique users, access controls, e-signatures with meaning, and secure audit trails for picks, moves, shipments, and exception handling. GDP therefore spans warehouse operations, packaging and labeling, logistics planning, execution, and proof-of-delivery.

3) Core Controls Across Storage and Transport

Qualified facilities and equipment. Warehouses and cold rooms are qualified for capacity and environmental performance; monitoring systems are calibrated and alarmed; backup power and contingency plans are defined. Location discipline. Bin / Location Management prevents intermix of quarantined vs released stock and separates temperature zones. Picking logic. Directed Picking applies FIFO or FEFO based on item rules; barcode validation forces correct item/lot/expiry/UDI scans; and Dynamic Lot Allocation filters by attributes (temperature class, allergen, potency band, customer agreements). Packaging and ship-prep. Packing lists, labels, and documents are bound to current masters under Document Control; tamper-evident seals are recorded; coolants and indicators are matched to lane time and ambient risk. Transport management. Carriers and lanes are qualified with thermal mapping and performance data; manifests capture SSCCs and seal numbers; hand-offs record custody. Event capture. Ship, depart, arrive, and receive events are recorded in traceability systems (e.g., EPCIS) to maintain forward/backward visibility. Exception handling. Overage/shortage/damage, temperature excursions, delays, or seal breaks trigger holds and Deviations/NCs with photos, data logs, and reason codes; QP/QA disposition is documented, potentially impacting Finished Goods Release status downstream.

4) Qualification of Partners, Lanes, and Packaging Systems

GDP relies on proven performance, not promises. Supplier qualification for 3PLs and carriers evaluates GxP understanding, infrastructure, SOPs, training, data integrity posture, and incident history. Audits confirm segregation, pest control, security, calibration, and incident CAPA. Lane qualification uses historical weather, transit times, and risk assessment to choose packaging and coolant loads that maintain validated conditions beyond the worst credible delay; data loggers from pilots feed acceptance decisions and trigger improvements. Packaging qualification treats shippers, gel packs, and phase-change materials as controlled components; artwork and labels are versioned; reuse rules are explicit. Where customers require minimum remaining shelf life on receipt, reservation logic narrows candidates before FEFO; shipping documents display both expiry and minimum-life commitments so receiving can verify without guessing.

5) Data Integrity & Records

GDP evidence must be ALCOA+: attributable (to people, devices, carriers), legible, contemporaneous, original/true copy, accurate, complete, enduring, and available. In practice this means: attributable scanner and HMI users; immutable audit trails for picks, label prints, seal application, loading, departures, and exception handling; synchronized time sources across WMS/TMS/temperature devices; retention of raw data from loggers; and proof that released items stayed within condition windows from dock to dock. When distribution interfaces with ERP/LIMS/labeling, acknowledgements and reconciliation reports ensure no blind spots; where barcoded expiry or UDI is present, captured data must appear in the shipment record and—where applicable—customer ASN. Archive strategies must preserve readability and linkage to the governing master procedures and training records (see Document Control and Data Retention & Archival).

6) Common Failure Modes & How to Avoid Them

• Policy says GDP; system allows anything. SOPs require FEFO or temperature checks, but WMS lacks interlocks. Fix: hardcode rules into tasks and scans; block progression without evidence.
• Packaging mismatch to lane. “Summer” packout used in winter or vice versa. Fix: lane-specific packouts with automatic selection and sign-off prompts.
• Seal and count gaps. Seals applied but never recorded; counts verified verbally. Fix: scan seal IDs and SSCCs; require dual verification on high-risk loads.
• Temperature data stranded. Logger files not tied to the shipment. Fix: attach raw files at ship or receive; hash and store with shipment record.
• Reservation starvation. Customer minimum-life promises hold long-dated stock indefinitely. Fix: periodic review and expiry-aware allocation rules.
• Label/version drift. Shipping docs or labels out of sync with masters. Fix: enforce Document Control and print-from-source only.
• Weak incident triage. Excursions logged as “FYI.” Fix: open Deviation/NC, assess risk to lots/customers, and link to CAPA when systemic.
• Unqualified partners. Spot-market carriers without GDP competence. Fix: approved vendor lists with scope, audits, and performance metrics.

7) Metrics That Prove GDP Control

Monitor temperature/humidity excursion rate per thousand shipments and mean excursion magnitude/time; FEFO adherence and blocked non-FEFO attempts at pick; damaged/short/over counts per lane; seal discrepancy rate; documentation completeness at ship and receive; on-time delivery vs commitment; minimum remaining shelf life at receipt; incident closure time; and mock-recall time-to-trace using EPCIS/SSCC. Trend by 3PL, carrier, lane, season, and product class; feed results into management review alongside APR/PQR and CPV insights.

8) How This Fits with V5

V5 by SG Systems Global turns GDP from SOP intent into enforced behavior. In V5 WMS, Directed Picking enforces FIFO/FEFO with expiry-aware queues and barcode validation; Dynamic Lot Allocation filters by attributes like temperature class and allergen; and Bin / Location zoning keeps released stock segregated from quarantine and cold from ambient. Packout workflows bind label and document templates under Document Control, capture seal IDs and SSCCs, and require dual verification on risk-tagged shipments. Temperature management integrates logger IDs and file attachments at ship/receive; exceptions open Deviations/NCs with photos and data files attached, routing through Approval Workflow. Event capture publishes EPCIS ship/receive states; Batch Genealogy renders forward/backward visibility instantly for recalls. QA views GDP KPIs alongside Finished Goods Release readiness, while Data Integrity and Part 11 controls secure users, signatures, and audit trails across WMS, MES, and labeling. For performance, V5 provides lane analytics (excursions by route/season), seal discrepancy dashboards, and FEFO adherence heatmaps that drive supplier and carrier scorecards.

9) FAQ

Q1. Does GDP require cold chain loggers on every shipment?
Not universally—risk determines monitoring. High-risk or temperature-sensitive products typically require lane-qualified packaging and periodic or continuous monitoring, with data attached to the shipment record for disposition and audits.

Q2. How does GDP interact with FEFO?
FEFO prioritizes soonest-to-expire lots among eligible candidates; GDP ensures the chosen lots stay within conditions and identity through to receipt. The WMS should apply FEFO, then package and track under GDP controls without manual workarounds.

Q3. What proves GDP compliance during inspection?
A coherent evidence set: qualified facilities/lanes, executed packout records, seal and SSCC scans, temperature/humidity data tied to the shipment, EPCIS shipping/receipt events, and closed deviations with risk assessments and CAPAs where needed.

Q4. Can we ship during an open distribution deviation?
Only if risk is assessed and justified, containment is in place, and QA/QP authorizes with conditions. High-risk deviations (e.g., uncontrolled temperature) typically require hold pending evaluation.

Q5. How is GDP validated?
Through a combination of facility qualification, packaging and lane qualification, and WMS/TMS process validation under CSV principles—testing interlocks, scans, packout rules, data capture, audit trails, and exception routing with time-synchronized systems.

Related Reading
• Release & Records: Finished Goods Release | CoA | Batch Release | Batch Genealogy
• Warehouse & Picking: Directed Picking | Bin / Location Management | Dynamic Lot Allocation | Barcode Validation
• Governance & Integrity: Data Integrity | 21 CFR Part 11 | Document Control | Deviation / NC
• Traceability & Events: EPCIS | FIFO | Expiration & Shelf-Life Control