{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-7",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-7.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/7",
  "kind": "division",
  "number": null,
  "heading": "Quality assurance programme",
  "text": "Purpose: to determine whether the mechanisms used to assure management that studies are conducted in accordance with GLP principles are adequate.\nThe head of the QA unit should be asked to demonstrate the systems and methods for QA inspection and monitoring of studies, and the system for recording observations made during QA monitoring. Inspectors should check:\nthe qualifications of the head of QA, and of all QA staff,\nthat the QA unit functions independently from the staff involved in the studies,\nhow the QA unit schedules and conducts inspections, how it monitors identified critical phases in a study, and what resources are available for QA inspections and monitoring activities,\nthat where studies are of such short duration that monitoring of each study is impracticable, arrangements exist for monitoring on a sample basis,\nthe extent and depth of QA monitoring during the practical phases of the study,\nthe extent and depth of QA monitoring of routine test facility operation,\nthe QA procedure for checking the final report to ensure its agreement with the raw data,\nthat management receives reports from QA concerning problems likely to affect the quality or integrity of a study,\nthe actions taken by QA when deviations are found,\nthe QA role, if any, if studies or parts of studies are done in contract laboratories,\nthe part played, if any, by QA in the review, revision and updating of SOPs.",
  "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/7",
    "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."
}