Avoid costly compliance pitfalls with GDP-certified storage
Are you risking your product’s integrity with inadequate storage solutions? In the race to bring life saving therapies to market, temperature-controlled storage often gets overlooked until something goes wrong. A temperature excursion, audit finding, or product loss can derail timelines, compromise product integrity, lead to costly product recalls, or affect patient safety. This is where GDP-certified storage under environmentally controlled storage comes in.
What is GDP-certified storage?
Good Distribution Practice (GDP) certification ensures that pharmaceutical products are stored and distributed under strictly controlled conditions. It’s not just about ticking a regulatory box; it’s about maintaining product integrity and protecting patient safety.
Why GDP-compliant storage matters
With regulators increasing their focus on supply chain integrity and storage compliance, companies must be proactive. The cost of non-compliance can be high:
- Failed audits
- Lost product batches
- Regulatory penalties
- Delays in getting products to market
- Compromised patient safety
Current EU regulatory expectations for GDP storage
Under GDP guidelines, companies involved in the storage and distribution of medicinal products must ensure that products are consistently stored, handled and transported under conditions that maintain their quality and integrity.
For companies operating or supplying to the EU market, GDP compliance is not optional, but a regulatory expectation enforced by authorities. These guidelines apply to all players in the supply chain, including pharmaceutical manufacturers, wholesalers, third-party logistics providers, and storage partners.
Key regulatory expectations include:
- Environmentally controlled conditions: Facilities must maintain precise storage temperatures (e.g. 15-25°C, 2-8°C, -20°C, or ultra-low temperature -60 to -90°C) with continuous monitoring and alarm systems in place to detect excursions.
- Traceability and documentation: Every movement of products must be recorded, ensuring full traceability from the point of receipt to final distribution.
- Qualified personnel and training: All staff involved in storage and distribution activities must be adequately trained and regularly assessed on GDP compliance.
- Risk management: A risk based approach must be taken to identify and mitigate potential issues across the supply chain.
- Audit readiness: Facilities are expected to be ready for regulatory inspections at any time and must be able to demonstrate full compliance with GDP requirements.
The benefits of outsourcing storage to a GDP-certified storage partner
For companies outsourcing their storage, selecting a GDP-certified storage partner is an important step in meeting regulatory requirements. It ensures that your products are stored under the same high standards expected internally while reducing the burden of in-house compliance management.
Q1 Scientific Belgium offers GDP-certified storage for a wide range of temperature conditions:
- 15-25°C (ambient or room temperature)
- 2-8°C (refrigerated)
- -20°C (freezer)
- -60 to -90°C (ultra low temperature)
Partnering with a GDP-certified storage provider like Q1 Scientific means:
- Product integrity and quality assurance: Strict temperature control prevents excursions that could impact storage conditions and lead to product loss.
- Regulatory compliance: Meeting EU GDP standards reduces the risk to customers of sanctions, product withdrawals, and risks during regulatory inspections.
- Reduced supply chain risk: Every step of Q1 Scientific’s storage process follows strict protocols to maintain product integrity. Secure storage minimises product loss, ensures business continuity, and protects patient safety.
- Operational efficiency and costs savings: Avoid costly product losses due to temperature deviations and eliminate the need for investment in additional warehouse space and compliance measures.
- Faster market access: Located in Belgium, close to manufacturing and testing sites, Q1 Scientific’s Belgium facility provides a central European distribution hub for customers with faster European market access.
How Q1 Scientific supports you with GDP-certified storage
Whether you’re a start-up preparing for your first trial or an established manufacturer expanding across Europe, our Belgium facility provides scalable, GDP-certified storage designed to meet your evolving needs.
Ready to reduce risk and gain a strategic advantage?