{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-6",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-6.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/6",
  "kind": "division",
  "number": null,
  "heading": "Organisation and personnel",
  "text": "Purpose: to determine whether the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate, and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.\nThe management should be asked to produce certain documents, such as:\nfloor plans,\nfacility management and scientific organisation charts,\nCVs of personnel involved in the type(s) of studies selected for the study audit,\nlist(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, method of application of test substance and name of study director,\nstaff health surveillance policies,\nstaff job descriptions and staff training programmes and records,\nan index to the facility's standard operating procedures (SOPs),\nspecific SOPs as related to the studies or procedures being inspected or audited,\nlist(s) of the study directors and sponsors associated with the study(ies) being audited.\nThe inspector should check, in particular:\nlists of on-going and completed studies to ascertain the level of work being undertaken by the test facility,\nthe identity and qualifications of the study director(s), the head of the quality assurance unit and other personnel,\nexistence of SOPs for all relevant areas of testing.",
  "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/6",
    "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."
}