{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-4",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-4.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/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Quality assurance programme",
  "text": "(1) Purpose: To determine whether the mechanisms used to assure manage ment that laboratory studies are conducted in accordance with good laboratory practice principles are adequate.\n(2) The head of the quality assurance unit should be asked to demonstrate the systems and methods of quality assurance inspection and monitoring of studies, and the system for recording observations made during quality assurance monitoring. Inspectors should check—\nthe qualifications of the head of quality assurance and of all quality assurance staff,\nthat the quality assurance unit functions independently from the staff involved in the studies,\nhow the quality assurance unit schedules and conducts inspections, how it monitors identified critical phases in a study, and what resources are available for quality assurance inspections and monitoring activities,\nthat, where studies are of such short duration and monitoring of each study is impracticable, arrangements exist for monitoring on a sample basis,\nthe extent and depth of quality assurance monitoring during the practical phases of the study,\nthe quality assurance procedures for checking the final report to ensure its agreement with the raw data,\nthat management receives reports from quality assurance concerning problems likely to affect the quality or integrity of a study,\nthe actions taken by quality assurance when deviations are found,\nthe quality assurance role, if any, of studies or parts of studies done in contract laboratories,\nthe part played, if any, by quality assurance in the review, revision and updating of standard operating procedures.",
  "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/4",
    "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."
}