Paragraph 1 Pre-inspection

Purpose: To familiarise the inspector with the facility which is about to be inspected in respect of management structure, physical layout of buildings and range of studies.

Prior to conducting a laboratory inspection or study audit, inspectors should familiarise themselves with the facility which is to be visited. Any existing information on the facility should be reviewed. This may include previous inspection reports, the layout of the facility, organisation charts, study reports, protocols and curricula vitae(CVs) of key personnel. Such documents would provide information on—

• the type, size and layout of the facility,

• the range of studies likely to be encountered during the inspection,

• the management structure of the facility.

Inspectors should note, in particular, any deficiencies from previous laboratory inspections. Where no previous laboratory inspections have been conducted, a pre-inspection visit can be made to obtain relevant information.

Laboratories should be informed of the date and time of inspectors' arrival, the objective of their visit and the length of time they expect to be on the premises. This will allow the laboratory to ensure that the appropriate personnel and documentation are available. In cases where particular documents or records are to be examined, it may be useful to identify these to the laboratory in advance of the visit so that they will be immediately available during the laboratory inspection.