{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-15",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-15.json",
  "legislation": "eudr/2004/9",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-9",
  "path": "annex/I/part/B/division/15",
  "kind": "division",
  "number": null,
  "heading": "Standard operating procedures",
  "text": "Purpose: to determine whether the test facility has written SOPs relating to all the important aspects of its operations, considering that one of the most important management techniques for controlling facility operations is the use of written SOPs. These relate directly to the routine elements of tests conducted by the test facility.\nThe inspector should check that:\neach test facility area has immediately available relevant, authorised copies of SOPs,\nprocedures exist for revision and updating of SOPs,\nany amendments or changes to SOPs have been authorised and dated,\nhistorical files of SOPs are maintained,\nSOPs are available for, but not necessarily limited to, the following activities:\n(i) receipt; determination of identity, purity, composition and stability; labelling; handling; sampling; usage; and storage of test and reference substances;\n(ii) use, maintenance, cleaning, calibration and validation of measuring apparatus, computerised systems and environmental control equipment;\n(iii) preparation of reagents and dosing formulations;\n(iv) record-keeping, reporting, storage and retrieval of records and reports;\n(v) preparation and environmental control of areas containing the test systems;\n(vi) receipt, transfer, location, characterisation, identification and care of test systems;\n(vii) handling of the test systems before, during and at the termination of the study;\n(viii) disposal of test systems;\n(ix) use of pest control and cleaning agents;\n(x) quality assurance programme operations.",
  "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/2004/9/annex/I/part/B/division/15",
    "retrieved_at": "2026-11-01T15:22:51.196773+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."
}