{
  "url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-1/division-1.1/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-1/division-1.1/division-2.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/1/division/1.1/division/2",
  "kind": "division",
  "number": "2",
  "heading": "At a minimum it should:",
  "text": "(a) ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;\n(b) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;\n(c) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;\n(d) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;\n(e) ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;\n(f) ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;\n(g) ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;\n(h) ensure, in the event of a multisite study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a principal investigator should be done according to established procedures, and should be documented;\n(i) ensure documented approval of the study plan by the study director;\n(j) ensure that the study director has made the approval study plan available to the quality assurance personnel;\n(k) ensure the maintenance of a historical file of all standard operating procedures;\n(l) ensure that an individual is identified as responsible for the management of the archive(s);\n(m) ensure the maintenance of a master schedule;\n(n) ensure that test facility supplies meet requirements appropriate to their use in a study;\n(o) ensure for a multisite study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;\n(p) ensure that test and reference items are appropriately characterised;\n(q) establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.",
  "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/1/division/1.1/division/2",
    "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."
}