Monitoring Authority Responsibilities
OECD Monograph 111 also sets out detailed advice for monitoring authorities and Inspectors on the conduct of test facility inspections in the following four sections. Click on them to reveal more.
This provides general guidance for inspectors on the conduct of Good Laboratory Practice compliance inspections.
This includes pre-inspection preparation, some logistics and the starting conference for an inspection, followed by a list of items that the Inspector could examine.
These can be a review of on-going or completed studies - the objective is to reconstruct the study from relevant records.
Inspection Completion - outlines activities covered later in this module.
