GDP COMPLIANT STORAGE

GDP compliant pharmaceutical storage for the German market

Build a pharmaceutical storage operation around your product requirements. Our Cheb warehouse provides a 20,000-pallet-position capacity base for supplying Germany, with professional oversight of GDP activities and project-specific storage, data and distribution processes.

Illustration of temperature-controlled pharmaceutical storage and transport — GDP compliant pharmaceutical storage
Illustration of temperature-controlled pharmaceutical storage and transport — GDP compliant pharmaceutical storage

AT A GLANCE

GDP compliant storage: the operating scope

GDP compliant storage combines suitable storage conditions with controlled stock status, batch and expiry records, trained personnel and documented quality decisions. Explore pharmaceutical warehousing for Germany →

Pharmaceutical storage from goods receipt to dispatch

A pharmaceutical warehouse must control more than space. The operating model covers receipt checks, quarantine, released stock, picking and documented dispatch. Product status, approved storage conditions, packaging, stock volumes and recipient types determine the required zones and procedures. The warehouse is in Cheb, Czechia, and serves the German market. Storage, transport coordination and regulatory responsibilities are defined separately in the agreement.

  • Product-specific storage assessment
  • Receipt and quantity checks
  • Quarantine and released stock
  • Quality agreement before go-live

Temperature mapping and continuous monitoring

Temperature mapping assesses the distribution of temperatures within the intended storage area under representative conditions. Monitoring then follows the agreed measurement points with suitable calibrated equipment. Alarm limits, response times, escalation contacts and power-failure procedures are documented. Significant changes to equipment, layout or use trigger an assessment of whether mapping needs to be repeated.

  • Risk-based temperature mapping
  • Calibrated sensors
  • Monitoring and alarm response
  • Documented temperature excursions

Batch traceability, expiry dates and FEFO

Batch numbers, expiry dates and stock status support traceable inventory movements. First Expiry, First Out (FEFO) prioritises the earliest suitable expiry date, subject to release status and minimum remaining shelf life. Goods movements must allow affected batches to be located and blocked promptly during a recall or quality investigation.

  • Batch and expiry records
  • Minimum remaining shelf life
  • FEFO picking rules
  • Inventory reconciliation and movement reports

Returns, quarantine and recall readiness

Returned medicines do not automatically re-enter saleable stock. Identity, condition, storage and transport history and the documented product status must be assessed by the responsible function. Deviations are investigated and corrective and preventive actions are assigned where required. Recall contacts, stock blocks and data exports form part of the agreed operating process.

  • Quarantine pending assessment
  • Deviation investigation and CAPA
  • Batch-specific stock blocks
  • Defined recall responsibilities

GDP oversight and the authorised activity scope

Professional oversight applies to GDP activities. The legal entity, site, wholesale authorisation, responsible person and authorised scope must match the actual operation. Repacking, relabelling and other manufacturing-related activities require separate assessment of the applicable authorisations. Evidence is checked before operational start; a general warehousing description is not a substitute for that review.

Ambient and cold-chain storage requirements

Controlled room temperature and refrigerated storage are assessed against the approved product information. A request for 15–25 °C or 2–8 °C needs a suitable zone, monitoring, excursion handling and a defined transport handover. The stated total pallet capacity does not mean that the whole warehouse is refrigerated. Temperature-zone availability is confirmed for each project.

Get a pharmaceutical storage quote

A useful quotation starts with average and peak pallet inventory, temperature requirements, inbound and outbound movements, order lines, picking units and reporting needs. Larger projects can typically be onboarded in 2–3 weeks once the scope, documentation, quality agreement, master data and interfaces are complete. Additional audits or qualification work may extend the schedule.

STORAGE CONDITIONS

Temperature-controlled warehousing by product requirement

These ranges describe requirements to assess. Product information and confirmed zone suitability determine availability for an individual project.

TemperatureProduct requirementControls to assess
2–8 °CRefrigerated medicines where required by the approved product informationProject-confirmed cold room, temperature mapping, continuous monitoring, alarms and a defined cold-chain handover
15–25 °CControlled room temperature where specified for the productSuitable storage zone, temperature mapping, calibrated sensors, monitoring and excursion assessment
Product-specificNarrower or different storage limitsIndividual assessment of product requirements, stability information, packaging and the complete handling process

PROJECT STEPS

From requirements to routine operation

  1. 01

    Product and volume profile

    Record product status, temperature requirements, pallet inventory, orders and the target market.

  2. 02

    Quality and authorisation review

    Agree the activity scope, responsibilities, quality agreement and required evidence.

  3. 03

    Zone and data preparation

    Confirm storage suitability, monitoring, master data, interfaces and escalation procedures.

  4. 04

    Receipt and storage

    Check identity, quantity, visible condition, temperature records and stock status.

  5. 05

    Picking and dispatch

    Select suitable stock by batch and expiry, check the order and document the handover.

  6. 06

    Operational review

    Review performance, deviations, CAPA, returns and changes.

FREQUENTLY ASKED QUESTIONS

Questions about gdp compliant storage

What does GDP compliant storage mean?+

It means controlling the quality and integrity of medicinal products through suitable storage conditions, documented processes, traceability, trained personnel and defined handling of deviations, returns and recalls.

Where is the pharmaceutical warehouse located?+

The warehouse is in Cheb, Czechia, close to the German border. It is used as an EU storage base for supplying the German market.

Is refrigerated storage at 2–8 °C available?+

Suitability and availability are checked against the product, volume, handling requirements and start date. Total warehouse capacity is not a statement of available cold-room capacity.

How long does warehouse onboarding take?+

Larger projects can typically start within 2–3 weeks when scope, authorisations, documentation, master data and interfaces are agreed. Extra qualification or audit requirements are scheduled separately.

What determines pharmaceutical storage costs?+

Pallet inventory, temperature zone, goods movements, picks, quality requirements, returns, reporting and additional services determine the quotation.

Are returns automatically released for sale?+

No. Returns remain under a controlled status until the agreed assessment and decision have been completed.

REGULATORY BASIS

GDP requirements and project evidence

The process descriptions refer to the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Site, legal entity and authorised activity scope must be verified before project start through the competent authority and relevant EudraGMDP records. SÚKL is the national medicines authority for Czech sites.

English content updated: 11 October 2026 · Pharmaceutical contact: Martin Didunyk, licensed pharmacist.

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