The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice.
OECD Principles of Good Laboratory Practice
TMQA has worked with many GLP laboratories over the years providing independent, third-party audits on behalf of sponsors who have contracted out their GLP studies.
We also provide a raft of valuable GLP services to smaller companies, for example: help developing and implementing GLP, providing top-up audit support when their own resource is busy or even running their entire QA programme. All of which means that they only have to pay for the QA services they need, when required.
With established expertise in both GLP and GCP, TMQA is also excellently placed to provide Good Clinical Laboratory Practice (GCLP) support to Clinical Laboratories.
TMQA’s Laboratory (GLP & GCLP) Services
Preparing the study
- Development of Quality Management Systems
- Gap analysis
- Vendor selection inspections
- Study plan / protocol audits
Performing the study
- In-life audits
- Facility / systems / process inspections
- Vendor oversight
Completing the study
- Data and report audit
Regulatory Authority Inspection Preparation
- Review of your study / QMS documentation
- Interview readiness training
- Mock inspections of your systems and procedures
- Representing you during inspections
Our support covers both regulatory work and non-regulated research, where there may not be a legal requirement for QA, the benefits of a QMS in ensuring robust research and development are well established.