The laboratory has been accredited in compliance with the Good Clinical Laboratory Practice (GCLP) standard, as published by the Research Quality Association (RQA), ISBN 978-1-904610-00-7. This is a quality system for laboratories that analyse samples from Clinical Trials in accordance with Good Clinical Practice (GCP) regulations.
GCLP accreditation allows the DRUC Laboratory to demonstrate to study sponsors that we operate to a standard that maintains patient confidentiality and ensures their rights in addition to demonstrating the reliability, quality and integrity of the data that we produce. This is achieved by working to a Quality Management System covering aspects such as sample receipt, handling, testing, storage, data analysis and reporting of data arising from the sample analysis of clinical trials.
Having a Quality Facilitator as a core part of the DRU Cymru Laboratory team, ensures that the whole Quality Management System is monitored through regular audits and kept up to date.
To maintain our GCLP accreditation, the DRU Cymru Laboratory undergoes an independent inspection which covers the following areas:
- Equipment and Calibration Records
- Sample Receipt & Storage
- Sample Identification & Analysis
- Review & Acceptance of Results
- Reporting Results
- Archives and Documentation Retention
- Project planning and scheduling
- Study analytical plans and protocols
- Quality Audit Program
- Standard Operating Procedures
- Staff Training Records
- QC Program
- Computer System