Quality & Compliance
At Q1 Scientific we maintain an extensive (Quality Management System) QMS to control and manage every aspect of our sample storage and management service.
GMP Certification
Compliance with Good Manufacturing Practices (GMP) is a mandatory aspect of pharmaceutical manufacturing, the ultimate goal being the safeguarding of patient health and the provision of high quality and efficacious medicines. The Q1 Scientific facility works to GMP & Good Distribution Practices (GDP) and the Health Products Regulatory Authority (HPRA) have audited Q1 Scientific to both standards previously.
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.
While Q1 Scientific has always operated to GMP standards, in line with the pharmaceutical industry, becoming ISO 9001 certified further enhances our competitiveness as an outsourced stability storage service provider, and better positions us to meet the ever-changing demands and expectations within the pharmaceutical and medical device industry.
Regulatory Bodies
One of the most significant accreditations Q1 Scientific has been given is GMP Manufacturing Certification following two successful HPRA audits in 2013 and 2015. This accreditation shows that Q1 Scientific is compliant with all GMP practices and gives confidence in our ability to store your products. Although the HPRA officially announced in 2018 they would not be continuing to audit storage facilities, the HPRA audited Q1 Scientific in 2018 for the storage of controlled drugs and active substances and issued accreditation for these in line with GDP compliance ASR11870/00001 (AUR21/060).
Q1 Scientific was also visited by the FDA in August 2014, 2017 & 2018, and the Saudi FDA in November 2014 as part of a client audit.
Quality Management System
In 2021, Catherine O’Brien our Quality Manager introduced an electronic QMS (eQMS) allowing the entire team to collaborate seamlessly with a full digital record of all activity.
The new eQMS is fully compliant with 21 CFR part 11, EU Annex 11 and supports ISO 9001, 13485, 14791 and 27001. In addition, we have completed full system validation checks for compliance.
Although paper-based processes have been the standard for decades, they are more time consuming, prone to human error and require someone to be physically located on site. Some of the key benefits of our new eQMS include the ability to track activities with full traceability and reporting functionality such as:
- Document Management
- Training
- Change Control
- Deviations
- Quality Events
- CAPA Management
- Risk Assessments
- Customer Complaints
- Audit Management
- Supplier Management
With the new eQMS we are eliminating non-value add activities so that we can spend more time on value-add activities. Finally, it’s another measure for mitigating regulatory risk. Managing regulatory risk, compliance, and certification are critically important objectives for our Quality team.
Documentation
We understand that our customers require consistency, traceability, and reliability, therefore all documentation is controlled through our extensive eQMS.
Reaching through every part of our business, our documentation is the foundation of our client service guarantee whilst maintaining compliance with regulatory agency requirements. All of our SOPs and documentation also ensure that our outsourced stability storage service seamlessly integrates with your existing business needs. All of our documentation is verified by our Quality team.
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 both internal and external audit programs.
Environmental Monitoring Compliance
Compliance and visibility underpins everything that we do at Q1 Scientific. As such, we have invested in the best of storage monitoring and reporting technologies that are meticulously validated and document-controlled prior to integration to site.
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 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 recorded by the monitoring system, allowing an immediately response by personnel.
Back-up System
A back-up system is important for business continuity. Our facility is supported by an 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 our facility for all chambers in real time and this data is backed up off site every day.