# The Good Laboratory Practice Regulations 1997, Paragraph 1: The management’s responsibilities


(1) Laboratory management should ensure that the principles of good laboratory practice are complied with in laboratory premises.
(2) At a minimum it should—
(a) ensure that qualified personnel, appropriate facilities, equipment, and materials are available;
(b) maintain a record of the qualifications, training, experience and job description for each professional and technical individual;
(c) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for those functions;
(d) ensure that health and safety precautions are applied according to national and/or international regulations;
(e) ensure that appropriate standard operating procedures are established and followed;
(f) ensure that there is a quality assurance programme with designated personnel;
(g) where appropriate, agree the study plan in conjunction with the sponsor;
(h) ensure that amendments to the study plan are agreed upon and documented;
(i) maintain copies of all study plans;
(j) maintain a historical file of all standard operating procedures;
(k) for each safety study ensure that a sufficient number of personnel is available for its timely and proper conduct;
(l) for each safety study designate an individual with appropriate qualifications, training, and experience as the study director before the safety study is initiated. If it is necessary to replace a study director during a safety study, this should be documented;
(m) ensure that an individual is identified as responsible for the management of the archives.

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Source: https://www.legislation.gov.uk/uksi/1997/654/schedule/1/paragraph/1 (the official version)
Page: https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.