"Farma Research Animal Health: Professionals for Veterinary Projects."

Quality

GLP

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 15-years experience with GLP in veterinary studies. The organization is inspected by the Dutch GLP inspectorate on a regular base (once in 2 years).

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.

More and more we perform multi-site studies, in which we co-operate with other GLP organizations. Farma Research Animal Health acts in these studies as Test Facility, responsible for Lead Quality Assurance and Study Director. Or we act as Test Site and are responsible as Principal Investigator. We are very experienced in the organization of muli-site studies with a complex structure: combination of GLP and other quality systems like ISO and VICH-GCP. In these studies Farma Research Animal Health is responsible for the total organization and prepares the study report.

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. Quality Assurance staff is not involved in the conduct of the study, other than in their role of auditor.

Every report contains a statement from (Lead) QA, relating to the quality assurance activities during the study. In the GLP Statement in the report the Study Director indicates the extent to which the work complies with the GLP Principles.

VICH-GCP

Field trials are performed in accordance with VICH-GCP.
In these studies a monitoring program is included.

But on request of the Sponsor 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 will contain a QA Statement.