{
  "url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-7/division-4",
  "json_url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-7/division-4.json",
  "legislation": "eudr/2004/10",
  "legislation_title": "Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-10",
  "path": "annex/I/section/II/division/7/division/4",
  "kind": "division",
  "number": "4",
  "heading": "Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.",
  "text": "1..\nTest and reference items\nReceipt, identification, labelling, handling, sampling and storage.\n2..\nApparatus, materials and reagents\n(a)\nApparatus:\nuse, maintenance, cleaning and calibration\n(b)\nComputerised systems:\nvalidation, operation, maintenance, security, change control and back-up\n(c)\nMaterials, reagents and solutions:\npreparation and labelling.\n3..\nRecord keeping, reporting, storage, and retrieval\nCoding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.\n4..\nTest system (where appropriate)\n(a) Room preparation and environmental room conditions for the test system.\n(b) Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.\n(c) Test system preparation, observations and examinations, before, during and at the conclusion of the study.\n(d) Handling of test system individuals found moribund or dead during the study.\n(e) Collection, identification and handling of specimens including necropsy and histopathology.\n(f) Siting and placement of test systems in test plots.\n5..\nQuality assurance procedures\nOperation of Quality Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/10/annex/I/section/II/division/7/division/4",
    "retrieved_at": "2026-11-01T15:22:51.082187+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}