The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.
Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
