# The Good Laboratory Practice Regulations 1997, Paragraph 3: Organisation and personnel


(1) Purpose: To determine whether: the laboratory has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate; and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.
(2) The management should be asked to produce certain documents, for example—
floor plans,
facility management and scientific organisation charts,
CVs of key personnel involved in the type(s) of studies selected for the study audit,
list(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, route of administration and name of study director,
staff training and health surveillance policies, where such policies have been established,
staff training records where available,
an index to the facility’s standard operating procedures,
specific standard operating procedures related to the studies or procedures being inspected or audited,
list(s) of the study directors associated with the study(ies) being audited.
(3) The inspector should check, in particular—
lists of on-going and completed studies to ascertain the level of work being undertaken by the laboratory,
the identity and qualifications of the study directors, the head of the quality assurance unit and other key personnel,
existence of standard operating procedures for the relevant areas of testing.

---
Source: https://www.legislation.gov.uk/uksi/1997/654/schedule/2/paragraph/3 (the official version)
Page: https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.