The Good Laboratory Practice Regulations 1997

Retention

26.—(1) The following should be retained for the period specified by the appropriate authorities—

(a) the study plan, raw data, samples, specimens and the final report of each safety study;

(b) records of all inspections and audits performed by the quality assurance programme;

(c) summary of qualifications, training, experience and job descriptions of personnel;

(d) records and reports of the maintenance and calibration of equipment;

(e) the historical file of standard operating procedures.

(2) Samples and specimens should be retained only as long as the quality of the preparation permits evaluation.

(3) If a laboratory or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor of the safety study.