OECD: A step-wise approach for the verification process of the GLP Status of Non-Clinical Safety Studies

The OECD recently published, in the series on principles of Good Laboratory Practice (GLP) and compliance monitoring, a guidance document for receiving authorities on the review of the GLP status of non-Clinical safety studies (document 20).

This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.

Indeed, this guidance promotes an adequate and time-efficient evaluation of the GLP status of nonclinical safety data, offering a step-wise approach of the GLP verification process.

If there is doubt on the GLP status of the data, the assessor should consult the relevant national GLP Monitoring Authority to discuss the impact and potential consequences of any GLP-related issues identified during the evaluation process before accepting GLP claims on the submitted data or requesting a GLP inspection and/or study audit.

 

To download: 

OECD Document 20 (ENV/JM/MONO(2019)25) Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies

 

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