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

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)

Apparatus, materials, reagents and specimensU.K.

Purpose: to determine whether the test facility has suitably located, operational apparatus in sufficient quantity and of adequate capacity to meet the requirements of the tests being conducted in the facility and that the materials, reagents and specimens are properly labelled, used and stored.

The inspector should check that:

  • apparatus is clean and in good working order,

  • records have been kept of operation, maintenance, verification, calibration and validation of measuring equipment and apparatus (including computerised systems),

  • materials and chemical reagents are properly labelled and stored at appropriate temperatures and that expiry dates are not being ignored. Labels for reagents should indicate their source, identity and concentration and/or other pertinent information,

  • specimens are well identified by test system, study, nature and date of collection,

  • apparatus and materials used do not alter to any appreciable extent the test systems.