What is GDP‑certified storage?
GDP storage refers to the regulated storage of medicinal products (human or veterinary) in accordance with EU Good Distribution Practice guidelines.
It ensures pharmaceutical products are stored, monitored, and handled under validated temperature and security conditions to maintain product quality, patient safety, and regulatory compliance throughout the supply chain.
Q1 Scientific provides GDP‑certified storage across a full range of tightly controlled and validated storage conditions including:
- 15–25°C (ambient), with optional humidity control at 60%
- 2–8°C (refrigerated)
- –20°C (freezer)
- –60 to –90°C (ultra-low temperature)
From receipt to release, every product benefits from continuous monitoring, audit-ready documentation, and full chain of custody.
How GDP storage differs from stability storage?
While stability storage focuses on testing product performance over time, GDP storage is concerned with maintaining product integrity during commercial and clinical distribution. GDP storage requires validated systems, traceability, excursion management, and audit‑ready documentation aligned with EU regulatory expectations.
Can I outsource GDP storage?
Yes. Many pharmaceutical, biotech, and medical device companies commonly outsource GDP storage to specialist providers, such as Q1 Scientific, with certified facilities and established quality systems. Outsourcing GDP storage allows companies to maintain regulatory compliance, reduce operational risk, and avoid the cost and complexity of managing validated storage, monitoring, and audit readiness in house.
What temperature ranges are available?
GDP certified storage at Q1 Scientific is available across a full range of conditions including 15–25°C, 2–8°C, –20°C, and –60 to –90°C (ULT), all within validated, continuously monitored environments.
How do you ensure regulatory compliance?
Regulatory compliance is ensured through alignment with EU GDP guidelines, robust quality management systems, trained personnel, and validated facilities. Continuous temperature monitoring, documented deviation and CAPA management, full traceability, and audit ready documentation are maintained at all times, supporting inspections by EU competent authorities and customer audits.
Do you store clinical trial materials and commercial batches?
Yes. GDP certified storage supports both clinical trial materials and commercial pharmaceutical products. This includes investigational medicinal products, authorised medicines, APIs, intermediates, and medical devices. Storage is managed with the same level of control, traceability, and quality oversight to ensure compliance across clinical development and commercial supply chains.
Is GDP storage a regulatory requirement in the EU?
Yes. In the EU, organisations involved in the wholesale distribution of medicinal products are expected to comply with EU Good Distribution Practice guidelines to maintain product quality and integrity across the supply chain. GDP sets requirements for how medicines are obtained, held, stored, handled, and supplied, helping prevent quality issues and protecting patients.
What documentation is required for GDP storage compliance?
GDP compliance relies on maintaining clear, controlled documentation that demonstrates product integrity and control throughout storage and distribution. This typically includes temperature monitoring records, calibration and mapping evidence, deviation and CAPA records, training records, SOPs, and traceability documentation for receipt, storage, status control, and release.
How does GDP storage support audits and inspections?
GDP storage supports audits and inspections by ensuring facilities operate under validated conditions with documented processes, continuous monitoring, and quality oversight. EU GDP guidelines emphasise control of the distribution chain, documentation, and systems that allow inspectors and customers to verify product integrity and traceability.
How are temperature excursions managed in GDP storage?
Temperature excursions are managed through continuous monitoring, alarm escalation, documented investigation, and quality oversight. GDP expects consistent storage under suitable conditions and robust controls to maintain product quality and integrity across the distribution chain. When an excursion occurs, it should be assessed against product requirements, investigated under deviation procedures, and closed with appropriate corrective actions and documentation.
What is the difference between GDP and GMP storage?
GDP and GMP both protect product quality, but they apply to different parts of the lifecycle. GMP focuses on controlled manufacturing and quality during production and packaging including the labelling, while GDP focuses on maintaining quality and integrity during storage and distribution within the supply chain.
What types of products require GDP compliant storage?
GDP compliant storage applies to medicinal products handled within the wholesale distribution supply chain, including authorised medicines and products supplied through distribution networks. GDP also applies to activities that involve holding and supplying medicinal products, with the objective of protecting quality and preventing falsified, expired and recalled medicines entering the legal supply chain. Where temperature, security, and traceability are critical, GDP compliant storage is typically expected.
