Manufacturing

De-Risk Your Global Manufacturing Supply Chain

Your supply chain’s weakest link is rarely the manufacturing step. It’s what happens before and after — the API staging, the quarantine management, the retain compliance, the recall response, the finished product distribution. GXP-Storage® is built for exactly those steps — from our FTZ 214 campus serving the Americas to our UK Golden Triangle facility supporting the EMEA region.

Risks That Compound Outside Your Facility’s Walls

Left unmanaged, outside supply chain risks don’t stay isolated—they escalate into delays, compliance pressure, and rising costs.

Siloed material management. Raw materials stored in one location, finished products elsewhere, quality materials scattered across additional providers — each operating in isolation with inconsistent standards and limited visibility.

Supply chain exposure before production begins. API and raw material delays are among the leading causes of manufacturing schedule disruption. Without a cGMP-compliant buffer near your production site, your line is only as reliable as your most unreliable supplier.

Quarantine and recall response risk. When FDA enforcement action, product complaint investigation, or litigation hold triggers material isolation, the ability to rapidly segregate and document affected batches separates a managed response from a regulatory crisis.

The retain and records burden. Retain sample and batch records management is a regulatory requirement for the full product shelf life plus one year. Without a lifecycle-managed retention strategy, organizations accumulate compliance liabilities silently.

Global import costs. Organizations importing APIs from global suppliers pay duty, brokerage fees, and customs delays on every shipment. A single strategic buffer location in a Foreign Trade Zone changes that equation entirely.

Supply Chain Benefits Across the Full Manufacturing Lifecycle

When your supply chain is designed as a coordinated lifecycle—not a series of handoffs—it becomes a source of control, rather than risk. The benefits below show how integrated infrastructure drives continuity, compliance, and cost efficiency at every stage of manufacturing.

• Supply Chain Buffer & Staging: Decouple your manufacturing schedule from global API sourcing variability. cGMP-compliant capacity on demand absorbs inbound logistics variability and keeps your production line running.

• Quarantine & QA Release Governance: Physical segregation of quarantined, approved, rejected, and hold materials; GXP-Guardian® tracking every status transition with compliant release workflows that match your quality system.

• FTZ 214 Import Cost Reduction: Defer customs duties on imported APIs and raw materials. Weekly entry filing, direct delivery from port, and inverted tariff relief — structural supply chain cost advantages that compound across every global shipment.

• Recall & Legal Hold Readiness: Rapid batch isolation, chain-of-custody documentation, and regulatory response support when market actions, litigation holds, or regulatory authority requests require immediate material accountability.

• Retain & Batch Record Compliance: Lifecycle-managed retention tied to batch disposition and product approval status. Disposition triggered when the obligation is met — eliminating the silent cost of indefinite retain accumulation.

• Secure, GDocP-Compliant Distribution: Temperature-validated staging and distribution support — cold-chain documentation, serialization support, and GDocP-compliant records.

PURPOSE-BUILT FACILITIES

Our purpose-built, commissioned facilities with secure access-controlled environments provide millions of cubic feet of storage capacity across controlled ambient to cryogenic conditions that grow with you from discovery through development.

FULL VISIBILITY

Research materials and documentation can be visible through our proprietary GXP-Guardian®, the only system explicitly built for regulated material lifecycle management supported by a complete digital architecture.

CERTIFIED SOLUTIONS

From your first research sample to the day your commercial product ships globally, you maintain full visibility and control through a single, GAMP 5 and 21 CFR Part 11 validated system. Generate compliance documentation quickly. This is what industry leadership looks like.

WHY GXP-STORAGE

One Federated View of Your Inventory

GXP-Guardian® aggregates and harmonizes your manufacturing material data — quarantine status, QC release records, lot expiry, batch records, retain samples, distribution documentation — from every facility, contract manufacturer, and geography into one regulatory-compliant platform. Whether materials are staged at our FTZ 214 campus in RTP, held at our UK Golden Triangle facility, or in transit, you see one federated view of your global manufacturing inventory.

Raw Materials & APIs: Received, logged, and stored under validated conditions with comprehensive chain-of-custody documentation. Automated FEFO reporting and rotation to prevent expiry risk on high-value inventory.
Excipients & Primary Packaging: Staged and released under cGMP protocols with lot traceability and inventory rotation. Matched to production schedules to eliminate packaging line stoppages.
Finished Goods & Stability Samples: GDP-compliant finished product staging with cold-chain integrity, validated environmental monitoring, serialization support, and distribution documentation.

Retain Samples & Batch Records: Regulatory-compliant retention tied to batch disposition and product approval status — with lifecycle-managed schedules that trigger disposition when the obligation is met.
Recall, Legal Hold & Regulatory Materials: Rapid quarantine segregation and chain-of-custody documentation for voluntary withdrawals, FDA-initiated recalls, litigation holds, and regulatory authority requests.
Controlled Substances & Hazardous Materials: cGMP-compliant staging, access-controlled storage, and documented destruction — with full chain-of-custody through final disposition.

A Growing Global Network. Positioned Where You Operate.

GXP-Storage operates a growing network of international regulated material management sites in key geographies — strategically located near major life sciences clusters, manufacturing facilities, and multimodal logistics infrastructure.

AMERICAS (US – Research Triangle Park Region)

Primary consolidation hub for the Americas region
Foreign Trade Zone 214 — duty deferral and customs efficiency for imported APIs and materials
Port of Wilmington & Morehead City — deepwater East Coast seaport access
Raleigh-Durham International Airport — air cargo with nonstop routes to London and Paris
Carolina Connector rail intermodal terminal — road/rail/port connectivity
I-95 & I-40 — full Eastern Seaboard and U.S. interior access

EMEA (UK – Golden Triangle Region)

Heart of the UK’s Golden Triangle — direct access to Oxford, Cambridge, and London life sciences corridors
Port of Felixstowe — UK’s largest container port handling 40%+ of containerized trade
London Heathrow & Stansted — air cargo with nonstop routes to global pharma hubs
Heathrow & Stansted airport proximity — direct air freight to global hubs
East West Rail corridor — emerging Oxford-Cambridge connectivity
M1, M11 & A1(M) motorway access — full connectivity across England and to major ports

Where You Store Matters. Our Locations Are a Supply Chain Decision.

Most regulated storage providers ask you to bring your supply chain to them. GXP-Storage is positioned where your supply chain already moves — at the intersection of global trade routes, domestic logistics networks, and the regulatory jurisdictions your materials cross.

In essence, we’ve established a two-node global network — Americas and EMEA — that covers the primary transatlantic supply chain routes, supports both US FDA and EU regulatory requirements, and provides a single GXP-Guardian® platform view of your global manufacturing material inventory regardless of where it is held.

US Facility: Foreign Trade Zone 214, Nash County, North Carolina

GXP-Storage’s US headquarters and primary manufacturing support facility occupies a 30-acre campus in Nash County, NC — strategically positioned within Foreign Trade Zone 214 and serving as the primary consolidation hub for the Americas region. FTZ 214 is administered by the NC Department of Transportation across 22 counties, with Nash County benefiting from the Alternative Site Framework and providing access to the Raleigh-Durham Customs and Border Protection port of entry.

FTZ 214 Financial Advantages:

• Duty Deferral: Import APIs without triggering U.S. customs duties. Pay duty only when materials enter U.S. commerce — or not at all if exported.

• Weekly Entry: Consolidated customs entry once per week vs. per-shipment filing — reducing brokerage costs and administrative burden for high-frequency API flows.

• Inverted Tariff Relief: When finished product carries a lower duty rate than imported API, process in-zone and pay the lower rate — a structural advantage for global manufacturers.

• Direct Delivery: Goods move from vessel or aircraft directly to the FTZ facility without interim customs hold — critical for temperature-sensitive APIs and biologics.

UK Facility: Golden Triangle Region — Supporting EU Supply Chains

GXP-Storage’s UK site is located in the London–Oxford–Cambridge Golden Triangle — the heart of the UK life sciences ecosystem and the gateway to EU pharmaceutical markets. For multinational manufacturers navigating post-Brexit supply chain obligations, the UK facility provides harmonized regulated storage that operates under the same quality standards and the same GXP-Guardian® platform as the US site.

The UK facility is positioned near major UK pharmaceutical manufacturing clusters and logistics infrastructure — ensuring that European API flows, finished product staging, and regulatory archiving requirements are served with the same integrated, lifecycle-managed approach available in the US.

Explicitly Built for Regulated Material Lifecycle Management

GXP-Guardian® provides real-time inventory status management — quarantined, approved, rejected, and released — with automated expiry alerts, and AI-powered analytics that predict and prevent compliance risks before they occur. ISO 27001/27017/27018-certified for data security, SOC 1/2/3-certified for operational and financial controls, and FedRAMP-ready for government and highly regulated enterprises.

The Results:

Visibility & Control: A single, searchable view of every item across your research library. Know exactly what you have, where it is, and its condition — One Federated View.

Regulatory Confidence: One immutable chain-of-custody from receipt through final disposition — 21 CFR Part 11 and Annex 11 compliant. Inspection-ready at any moment.

Unified, AI-ready system of Record: One AI-ready system of record, standardized across every source — the data foundation your analytics strategy requires.

Data Centralization: Sample metadata, storage conditions, and disposition history unified in GXP-Guardian. No more reconciling spreadsheets, LIMS exports, and CRO manifests.

ISO 9001:2015-Certified: Quality management system independently verified — governing every storage and retrieval process your materials experience.

ISO 20387:2018-Certified: Biobanking management system independently verified — governing specimen integrity, traceability, and chain of custody from receipt to retrieval.

Enterprise-Grade Platform: ISO 27001/27017/27018-certified for data security, SOC 1/2/3-certified for operational and financial controls, and FedRAMP-ready for government and highly regulated enterprises.

Explore our gxp-guardian technology

Your Manufacturing Supply Chain Deserves a Specialist. Not a Warehouse.

Your manufacturing materials are not passive inventory—they are production-critical assets tied directly to release timelines, global distribution continuity, and regulatory compliance.

From Warehouse Complexity to Supply Chain Control

GXP-Storage provides integrated cGMP supply chain services from a strategic FTZ 214 location with multimodal logistics access — and mirrors that capability in the UK for EMEA coverage. Make the move now and start reaping the benefits of one partner, one platform and one view of your global manufacturing material inventory.

Speak to A Specialist

To learn about how we can help you manage your Manufacturing Supply Chain, download our information sheet.