Monitoring Authority Responsibilities
OECD Monograph 111 should be referred to when considering monitoring authority inspections as it:
- Advises on the preparation, conduct and completion activities for inspections and study audits
- Defines the term Inspector as a person who performs the test facility inspections and study audits on behalf of the national Good Laboratory Practice monitoring authority
- Describes inspection activities
Because of the diversity of facilities and variety of study types, it is recognised that technical expertise in particular disciplines may be needed to assist an Inspector.
Click here to find out the two main reasons for inspection
1. A routine activity carried out as part of the Good Laboratory Practice monitoring authority programme to assess the compliance of the facility. It includes at least one study audit or review.
2. A detailed audit or review of a specific study, carried out in response to a direct request, by a regulatory authority for example. This is sometimes referred to as a for-cause inspection.
