Good Laboratory Practice (GLP) QA support
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.