Quality Assurance

The quality system of Farma Research Animal Health is based on the Principles of Good Laboratory Practice (GLP).

The company is inspected by Dutch GLP Inspectorate on a regular base.

Within the quality system standardised 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.

Within the programme of Quality Assurance either study-based or non-study-based audits are conducted. The raw data and the final report are reviewed, to verify integrity of the reported results.

In multi-site studies Farma Research Animal Health can act as Test Facility and provides the Study Director and Lead-QA. If Farma Research Animal Health acts as Test Site, it provides the Principal Investigator and Test Site QA.

From each study a final report is prepared. This report contains a QA-statement, relating to the quality assurance activities during the study. In each report the Study Director/Principal Investigator indicates the extent to which the work complies with the GLP Principles.

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

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