Purpose: to determine whether the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate, and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.
The management should be asked to produce certain documents, such as:
floor plans,
facility management and scientific organisation charts,
CVs of personnel involved in the type(s) of studies selected for the study audit,
list(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, method of application of test substance and name of study director,
staff health surveillance policies,
staff job descriptions and staff training programmes and records,
an index to the facility's standard operating procedures (SOPs),
specific SOPs as related to the studies or procedures being inspected or audited,
list(s) of the study directors and sponsors associated with the study(ies) being audited.
The inspector should check, in particular:
lists of on-going and completed studies to ascertain the level of work being undertaken by the test facility,
the identity and qualifications of the study director(s), the head of the quality assurance unit and other personnel,
existence of SOPs for all relevant areas of testing.