{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-3",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-3.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/2/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Organisation and personnel",
  "text": "(1) Purpose: To determine whether: the laboratory 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.\n(2) The management should be asked to produce certain documents, for example—\nfloor plans,\nfacility management and scientific organisation charts,\nCVs of key 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, route of administration and name of study director,\nstaff training and health surveillance policies, where such policies have been established,\nstaff training records where available,\nan index to the facility’s standard operating procedures,\nspecific standard operating procedures related to the studies or procedures being inspected or audited,\nlist(s) of the study directors associated with the study(ies) being audited.\n(3) The inspector should check, in particular—\nlists of on-going and completed studies to ascertain the level of work being undertaken by the laboratory,\nthe identity and qualifications of the study directors, the head of the quality assurance unit and other key personnel,\nexistence of standard operating procedures for the relevant areas of testing.",
  "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/2/paragraph/3",
    "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."
}