{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-14",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-14.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/14",
  "kind": "division",
  "number": null,
  "heading": "Test and reference substances",
  "text": "Purpose: to determine whether the test facility has procedures designed (i) to ensure that the identity, potency, quantity and composition of test and reference substances are in accordance with their specifications, and (ii) to properly receive and store test and reference substances.\nThe inspector should check that:\nthere are written records on the receipt (including identification of the person responsible), and for the handling, sampling, usage and storage of tests and reference substances,\ntest and reference substances containers are properly labelled,\nstorage conditions are appropriate to preserve the concentration, purity and stability of the test and reference substances,\nthere are written records on the determination of identity, purity, composition, stability, and for the prevention of contamination of test and reference substances, where applicable,\nthere are procedures for the determination of the homogeneity and stability of mixtures containing test and reference substances, where applicable,\ncontainers holding mixtures (or dilutions) of the test and reference substances are labelled and that records are kept of the homogeneity and stability of their contents, where applicable,\nwhen the test is of longer than four weeks duration, samples from each batch of test and reference substances have been taken for analytical purposes and that they have been retained for an appropriate time,\nprocedures for mixing substances are designed to prevent errors in identification or cross-contamination.",
  "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/14",
    "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."
}