We take a look at the role of Quality Assurance (QA) in GLP at Oxford Analytical Services Ltd
The GLP definition of quality assurance is that quality assurance inspections can be of three types: study based, facility based and process based.
QA inspection programmes will often cover a broad range of activities but the risk associated with each activity may not be considered and/or reflected in the frequency and scope of the inspection. The adoption of a risk based inspection programme can allow QA to focus their resources in a more effective and proactive manner commensurate with the risk that an activity has on the GLP compliance status of the studies, facilities and systems.
The implementation of quality control activities can provide information on weaknesses associated with a given activity and may be used to direct the focus of the quality assurance programme.
So what’s the Quality Assurance process in our lab?
Here at Oxford Analytical our Quality Assurance is a defined independent system, designed to assure test facility management compliance within the principles of Good Laboratory Practice. This is to ensure our clients receive the highest quality of service possible.
Quality Assurance provides solid confidence that our processes and services meet the given quality requirements through systematic actions and activities. These include regular inspections on live processes, document audits along with general facility inspections.
All actions are reported to our test facility management and monitored through the company CAPA (Corrective and Preventive Actions). These actions enable Oxford Analytical to continually improve and provide even better service for our clients.
There is no such thing as a typical day in the Quality Assurance department as our team expertly handles the varied activities and responsibilities which support the laboratory and uphold compliance.
Quality Assurance are responsible for:
- Checking the raw data generated within the study is reflective of the reported data
- Verifying electronic data meets internal procedures and is produced in line with GLP
- Overseeing live inspections on study activities
- Reviewing Standard Operating Procedures (SOP’s) for compliance with regulatory updates and best practice
- Expertly preparing and approving new raw data sheets for analytical tests
- Appling industry and technical knowledge to audit final reports
- As well as reviewing and approving study plans and study plan amendments, our team goes beyond GLP audits and receives regular training on the regulations that govern our customers registrations too, so we ensure we have robust Study Plans!
And they still find the time for the occasional cuppa!
But it doesn’t stop there, Quality Assurance also carries out assessments to guarantee that appropriate training has been provided, enabling Oxford Analytical to ensure our staff deliver the highest calibre of work day after day. They have an oversight of all activities performed in our laboratory and use digital platforms for tracking performance and compliance, along with monitoring and reviewing any out of specification investigations.
It is a busy role requiring high attention to detail, a strong understanding of the GLP regulations and certainly a level of patience, but we love it!