{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-11",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-11.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/11",
  "kind": "paragraph",
  "number": "11",
  "heading": "Test and reference substances",
  "text": "(1) Purpose: To determine whether the laboratory has procedures designed—\n(i) to ensure that the identity, potency, quantity and composition of test and reference substances are in accordance with their specifications, and\n(ii) to properly receive and store test and reference substances.\n(2) The inspector should check that—\nthere are standard operating procedures for recording the receipt, and for the handling, sampling, usage and storage of test 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 standard operating procedures for the determination of identity, purity, composition, stability, and for the prevention of contamination of, test and reference substances, where applicable,\nrecords are kept of the composition, characterisation, concentration and stability 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": 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/11",
    "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."
}