The Good Laboratory Practice Regulations 1997

Starting conference

2.—(1) Purpose: To inform the management and staff of the facility of the reason for the laboratory inspection or study audit that is about to take place, and to identify the laboratory areas, study(ies) selected for audit, documents and personnel likely to be involved.

(2) The administrative and practical details of a laboratory inspection or study audit should be discussed with the management of the facility at the start of the visit. At the starting conference, inspectors should—

• outline the purpose and scope of the visit,

• describe the documentation which will be required for the laboratory inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed upon at this time,

• clarify or request information as to the management structure (organisation) and personnel of the facility,

• request information as to the conduct, side-by-side, of studies subject to good laboratory practice principles with others for which they are not applied,

• make an initial determination as to the parts of the facility to be covered during the laboratory inspection,

• describe the documents and specimens that will be needed for on-going or completed study(ies) selected for study audit.

(3) Before proceeding further with a laboratory inspection, it is advisable for the inspector to establish contact with the laboratory quality assurance unit.

(4) As a general rule, when inspecting a facility, inspectors will find it helpful to be accompanied by a member of the quality assurance unit.

(5) Inspectors may wish to request that a room be set aside for examination of documents and other activities.