GLP – Pre-clinical testing laboratory
GLP (Good Laboratory Practices) refers to the set of principles intended to assure the quality and integrity of non-clinical laboratory studies.
How does it work?
GLP (Good Laboratory Practices) requires two types of audits to be performed: Study Audits and Vendor Audits.
Analysis procedures (Study Audit) include but are not limited to: reviewing protocol and compliance to protocol, reviewing SOP and compliance to procedures, performing in-process study inspections, conducting data reviews, conduct reviews of draft and final reports.
Vendor Audits include but are not limited to: performing routine and qualification audits of contract laboratories, inspecting facilities and equipment, reviewing organization structure and SOP content, assessing qualification and training of personnel, assessing testing facilities operation including test and control articles, reviewing records, reports, and record/sample retention, assess data transfer process, assess QA unit.