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The Good Laboratory Practice Regulations 1997
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Storage and retention of records
15.—(1) Purpose: To determine whether the facility has generated adequate records and reports and whether adequate provision has been made for the safe storage and retention of records and materials.
(2) The inspector should check—
the archive facilities for the storage of study plans, raw data, final reports, samples and specimens,
the procedures for retrieval of archived materials,
the procedures whereby access to the archives is limited to authorised personnel and records are kept of personnel given access to raw data, slides, etc.,
that an inventory is maintained of materials removed from, and returned to, the archives,
that records and materials are retained for the required or appropriate period of time and are protected from loss or damage by fire, adverse environmental conditions, etc.
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