# Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance), Division: Starting conference

Extent: E+W+S+N.I.

Purpose: to inform the management and staff of the facility of the reason for the test facility inspection or study audit that is about to take place, and to identify the facility areas, study(ies) selected for audit, documents and personnel likely to be involved.
The administrative and practical details of a test facility 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 test facility 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 on at this time,
clarify or request information as to the management structure (organisation) and personnel of the facility,
request information as to the conduct of studies not subject to GLP principles in the areas of the test facility where GLP studies are being conducted,
make an initial determination as to the parts of the facility to be covered during the test facility inspection,
describe the documents and specimens that will be needed for on-going or completed study(ies) selected for study audit,
indicate that a closing conference will be held at the completion of the inspection.
Before proceeding further with a test facility inspection, it is advisable for the inspector(s) to establish contact with the facility's quality assurance (QA) unit.
As a general rule, when inspecting a facility, inspectors will find it helpful to be accompanied by a member of the QA unit.
Inspectors may wish to request that a room be set aside for examination of documents and other activities.

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Source: https://www.legislation.gov.uk/eudr/2004/9/annex/I/part/B/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.