The Good Laboratory Practice Regulations 1997

The management’s responsibilities

1.—(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.