Our Quality Assurance staff has years of experience in the CRO industry. QA carries out study-based audits of study phases and procedures and reviews the raw data and the final report to verify the integrity of the reported results. Independent from the studies, Quality Assurance periodically performs facility-based audits of systems and test locations.
GLP (Good Laboratory Practice)
Farma Research Animal Health is a GLP organization. Studies are performed in compliance with OECD Principles of Good Laboratory Practice. Owners and employees of Farma Research Animal Health have a more than 25-years experience with GLP in veterinary studies. The organization is inspected by the Dutch GLP inspectorate on a regular base (once in 2 years). For the most recent GLP certificate click here
Within the quality system, standardized systems, processes and facilities are documented in standard operating procedures (SOPs). Non-standard activities and facilities of studies are specified in the study or trial protocol.
In multi-site studies, in which we co-operate with other GLP (Good Laboratory Practice) organizations, Farma Research Animal Health acts as Test Facility, responsible for Lead Quality Assurance and Study Director. In these studies Farma Research Animal Health is responsible for the total organization and prepares the study report.
VICH-GCP (Good Clinical Practice)
Field trials are performed in accordance with VICH-GCP (Veterinary Good Clinical Practice) and in accordance with the actual guideline. In these studies a monitoring program is included. But a QA program can be included as well. As in GLP studies, QA carries out study-based audits, reviews the raw data and the final report. The study report contains a QA Statement.