{
  "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-15",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-1569/article-15.json",
  "legislation": "eur/2017/1569",
  "legislation_title": "Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-1569",
  "path": "article/15",
  "kind": "article",
  "number": "15",
  "heading": "Self-inspection by the manufacturer",
  "text": "The manufacturer shall conduct regular inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice. He shall take any necessary corrective action and to put in place any necessary preventive measures.\nThe manufacturer shall maintain records of all such inspections and any corrective action or preventive measures subsequently taken.",
  "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/eur/2017/1569/article/15",
    "retrieved_at": "2026-11-01T14:44:34.669471+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."
}