Q1 Scientific is a market leader in environmentally controlled stability storage services for the pharmaceutical, medical device and bioscience industries. Our clients include global leaders in the , medical device and life sciences industries.
At our GMP Certified facility we provide temperature and humidity controlled and monitored storage solutions in compliance with all pharmaceutical standards. By using Q1 Scientific for stability storage requirements companies have the flexibility to outsource this capital and management intense function while maintaining control on testing and R&D.
Q1 Scientific provides:
Stability Storage
All key ICH climatic zones are provided for long term, intermediate and accelerated stability trials.
Sample management and monitoring
The Q1 Scientific QMS is set up to manage stability samples from the initial protocol development through to defining pull points and delivering samples to the laboratory for analysis. Clients are provided with full visibility of actual monitoring data and details on all their samples on stability.
Our monitoring system is compliant with GMP/GLP/FDA (21 CFR Part 11), JCAHO, GAMP, ISO 19005 and USP 1079.
Photostability testing
For companies developing or manufacturing pharmaceutical drugs, a robust photostability testing process is essential to ensure product quality and regulatory compliance. Q1 Scientific carries out photostability studies to the client specifications in accordance with ICH Q1B.
Disaster recovery
Q1 Scientific can provide a primary or contingency storage solution with the option of a disaster recovery capability if required.
We have a disaster recovery procedure in place to cover any emergency transfer of samples from clients from individual batches to entire chambers. Clients can be assured that should one if their own stability chambers go down, Q1 Scientific can take the affected samples to avoid significant interruption to client stability studies.
Risk management
We provide primary or contingency storage solutions to help prevent uncertainty from impacting on our client’s core business activities.
Custom storage conditions for R&D
Q1 Scientific can provide custom-controlled temperature and humidity environments for research development work across the bioscience and pharmaceutical industries.
Retain sample storage
We provide temperature controlled (15C-25C) large scale retain storage. The unit is kept at optimal temperature using an industrial air handling unit. The space is temperature mapped to ensure there are no cold spots present. It is also continuously supervised through our independent temperature monitoring system.
Biological storage
Covering all common environments, including refrigerated and freezer storage, Q1 Scientific provides customised storage to client specification.
Client access
Clients have secure online access to their own real-time study progression and outcomes.
Heritage storage
Our state-of-the-art environmentally controlled and monitored storage facilities can accommodate the preservation of historic and artistic artefacts.
Compliance
Compliance and visibility underpin everything that we do. Our storage monitoring and reporting technologies are meticulously validated. The Q1 Scientific facility holds a Health Products Regulatory Authority (HPRA) Certificate of GMP with on-going biennial inspections.
Q1 cost benefits
The Q1 Scientific ‘Pay For Use’ model helps our clients achieve cost reduction and control through the elimination of waste, hidden maintenance costs and service and security overheads. Our capacity can be continuously adjusted to fit your requirements, making sure you have access to the storage capacity you need – when you need it. This enables our clients to concentrate on core activities central to their businesses, focusing on activity rather than infrastructure while maintaining control over testing and R&D functions. Reduction in capital investment in storage facilities and infrastructure means clients can optimise utilisation and ROI on existing stability infrastructure.
Q1 Scientific stability storage solutions can help you to reduce your costs and manage risk and compliance, while you concentrate on your core business activities.
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, medical device and life sciences industries.