The Q1 Facility
Q1 Scientific cGMP
From our facilities in Belgium and Ireland, we offer a variety of stability storage conditions across 50,000 sq ft of stability storage space. The vast expansion of Q1 Scientific has been exceptional with a 900% capacity increase over 10 years. At any given time, our dedicated team manages over 1000 stability study programmes.
At Q1 Scientific, our expert team and state-of-the-art cGMP storage facilities set us apart. With extensive validation and quality systems we provide a secure, transparent and trusted storage service for long term, intermediate and accelerated stability studies.
Waterford, Ireland
- 30,000 sq ft cGMP storage facility
- ICH and non-ICH stability storage for pharmaceutical, medical device and life science samples
- Storage for all key ICH climatic zones; suitable for long term, intermediate and accelerated stability trials.
- Ultra-low freezer storage down to -80˚C
- Custom controlled temperature and humidity conditions for R&D
- A choice of shared or exclusive walk-in rooms or ultra-low freezers
- Temperature-controlled transport
Liege area, Belgium
- 20,000 sq ft cGMP storage facility
- ICH and non-ICH stability storage for pharmaceutical, medical device and life science samples
- Storage for long-term, intermediate and accelerated stability studies including 2 – 8°C and 25°C / 60%RH and 40°C / 75%RH
- Ultra-low freezer storage down to -80˚C
- Custom controlled temperature and humidity conditions for R&D
- A choice of shared or exclusive walk-in rooms or ultra-low freezers
- Temperature-controlled transport
Security and monitoring systems
Stability studies are an important part of your product development process, so all our equipment is validated, all conditions tightly controlled, and all samples continuously monitored.
All environmental chambers are validated at installation and are regularly re-validated to ensure specified performance requirements are met. Temperature and humidity conditions are continuously monitored and recorded using a monitoring system which is compliant with FDA (21 CFR Part 11), GMP & GAMP 5.
The Q1 Scientific independent monitoring system centrally collates all storage data through a secure LAN to monitor each environmental chamber, allowing real-time information to be relayed to personnel immediately. A 24/7 alarm system is connected to each storage chamber to alert of any deviations in control parameters so any deviation is reported immediately and a swift response is activated by staff.
Back-up system
A back-up system is important for business continuity. Our facilities in Belgium and Ireland are supported by Uninterrupted Power Supplies and backup generators with an automatic cut over switch to cover any power outages or fluxes.
In the event of a network connection failure, the data storage and local alarm are not lost, and a notification is sent to inform of the connection failure. Data is stored at our facilities for all chambers in real time and this data is backed up off site every day.
Quality Management System
We maintain an extensive (Quality Management System) QMS to control and manage every aspect of our sample storage and management service. Our eQMS is fully compliant with 21 CFR part 11, EU Annex 11 and supports ISO 9001, 13485, 14791 and 27001. Managing regulatory risk, compliance, and certification are critically important objectives for our Quality team.
In 2022, Q1 Scientific became ISO 9001 certified following a successful audit of our QMS by the NSAI (National Standards Authority of Ireland), demonstrating compliance with these internationally recognised standards.
We understand that our customers require consistency, traceability, and reliability, therefore all documentation is controlled through our extensive eQMS.
“Q1 Scientific has provided us with an excellent resource for stability storage. The staff are very knowledgeable and friendly and show a great interest in our business. The security provided for critical samples is first class and allows us to know that our samples will be kept at the required conditions for the duration of our stability studies.”
Quality Control Manager, Pharmaceutical Company
Contact us
To discuss your stability storage requirements, contact our expert team today.