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.