The Good Laboratory Practice Regulations 1999

Facility management’s responsibilities U.K.

1.—(1) Each test facility management should ensure that the principles of good laboratory practice are complied with in its test facility.

(2) As a minimum it should—

(a) ensure that a statement exists which identifies the individuals within a test facility who fulfil the responsibilities of management as defined by the principles of good laboratory practice;

(b) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct or regulatory studies;

(c) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;

(d) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for those functions;

(e) ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;

(f) ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance programme is being performed in accordance with the principles of good laboratory practice;

(g) ensure that for each study an individual with the appropriate qualifications, training and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;

(h) ensure, in the event of a multi-site study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise any delegated phase of the study. Replacement of the principal investigator should be done according to established procedures, and should be documented;

(i) ensure documented approval of the study plan by the study director;

(j) ensure that the study director has made the approved study plan available to the quality assurance personnel;

(k) ensure maintenance of a historical file of all standard operating procedures;

(l) ensure that an indivdual is identified as reponsible for the management of the archives;

(m) ensure maintenance of a master schedule;

(n) ensure that test facility supplies meet requirements appropriate to their use in a study;

(o) ensure for a multi-site study that clear lines of communication exist between the study director, principal investigator, quality assurance programme and personnel;

(p) ensure that test and reference items are appropriately characterised;

(q) establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with the principles of good laboratory practice.

(3) When a phase of a study is conducted at a test site, test site management (if appointed) will have the responsibilities set out in sub-paragraph (2)(a) to (f), (h), (k) to (n), (p) and (q).