{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-1",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-1.json",
  "legislation": "uksi/1997/654",
  "legislation_title": "The Good Laboratory Practice Regulations 1997",
  "legislation_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997",
  "path": "schedule/1/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "The management’s responsibilities",
  "text": "(1) Laboratory management should ensure that the principles of good laboratory practice are complied with in laboratory premises.\n(2) At a minimum it should—\n(a) ensure that qualified personnel, appropriate facilities, equipment, and materials are available;\n(b) maintain a record of the qualifications, training, experience and job description for each professional and technical individual;\n(c) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for those functions;\n(d) ensure that health and safety precautions are applied according to national and/or international regulations;\n(e) ensure that appropriate standard operating procedures are established and followed;\n(f) ensure that there is a quality assurance programme with designated personnel;\n(g) where appropriate, agree the study plan in conjunction with the sponsor;\n(h) ensure that amendments to the study plan are agreed upon and documented;\n(i) maintain copies of all study plans;\n(j) maintain a historical file of all standard operating procedures;\n(k) for each safety study ensure that a sufficient number of personnel is available for its timely and proper conduct;\n(l) for each safety study designate an individual with appropriate qualifications, training, and experience as the study director before the safety study is initiated. If it is necessary to replace a study director during a safety study, this should be documented;\n(m) ensure that an individual is identified as responsible for the management of the archives.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1997/654/schedule/1/paragraph/1",
    "retrieved_at": "2026-10-29T12:22:49.085052+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."
}