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Inspection Report

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Serious Deviations

If a serious deviation from the Good Laboratory Practice Principles has been identified in the inspection report and this may have affected the validity of a study or studies, then the Inspector should report back to the national Good Laboratory Practice monitoring authority.

Action taken by the authority and/or the regulatory authority will depend on the nature and extent of the non-compliance and the national law.

Go to the next page to see the consequences of deviating from Good Laboratory Practice Principles.