Quality & Compliance
Quality & Compliance
Compliance with GMP is a mandatory aspect of pharmaceutical manufacturing, the ultimate goal being the safe-guarding of patient health and the provision of high quality and efficacious medicines.
GMP Certification
Q1 Scientific facility holds a Health Products Regulatory Authority (HPRA) Certificate of GMP Compliance of a Manufacturer.
Regulatory Bodies
To ensure Q1 Scientific maintains the same GMP standards expected of their clients the operations are subject to HPRA inspection for GMP compliance. Q1 Scientific was approved by the HPRA in May 2013 and Q1 Scientific has successfully completed a biennial HPRA GMP inspection in May 2015 with zero deficiencies cited.
Q1 Scientific was also visited by the FDA in August 2014 and the Saudi FDA in November 2014 as part of a client audit.
Quality Management System
At Q1 Scientific we maintain an extensive Quality Management System to control and manage every aspect of our sample storage and management service.
Documentation
Reaching through every part of our business, our documentation is the foundation of our client service guarantee whilst maintaining compliance with regulatory agency requirements. They also ensure our outsourced solution seamlessly integrates with your existing business needs. All our documentation is verified by our Quality Assurance Unit.
Reaching through every part of our business, our documentation is the foundation of our client service guarantee whilst maintaining compliance with regulatory agency requirements. They also ensure our outsourced solution seamlessly integrates with your existing business needs. All our documentation is verified by our Quality Assurance Unit.
Environmental Monitoring Compliance
Compliance and visibility underpins everything that we do. As such, we have invested in the best of storage monitoring and reporting technologies that are meticulously validated.
Rooms & Chambers
Q1 Scientific chambers and cabinets are state-of-the-art and are extensively qualified at installation. They are regularly re-validated to ensure specified performance requirements are met.
Monitoring System
Temperature and humidity 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 chambers generating real time information.
A 24/7 alarm system is connected to each storage chamber to alert of any deviations in control parameters recorded by the monitoring system and responded to immediately.
Back-up System
The facility is supported by Uninterrupted Power Supply and a backup generator with 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 the facility for all chambers in real time and this data is backed up off site every day.