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.

Training

All Q1 Scientific personnel are highly qualified to perform the requirements on site. On-going training is given to all personnel, and its practical effectiveness is periodically assessed through audit programs.

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

quality complianceQ1 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

Q1 Scientific BackupThe 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.