Directive 2004/9/EC of the European Parliament and of the CouncilShow full title

Organisation and personnel U.K.

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.