Responsibilities of test facility management and sponsor in a GLP environment.
Compliance with the Organisation for Economic Co-operation and Development (OECD) principles of good laboratory practice (GLP) is discussed in particular as regards the responsibility of the management of a test facility (TF) when performing a monosite study as compared to the responsibility in a multisite study. Other issues of interest in this context are dealt with, such as the qualification and training for professionals and technicians, the meaning of validity of standard operating procedures (SOP), the relation between management and quality assurance (QA), the role played by study plans, test and reference items, archives, master schedule, communication lines, validation of methods and calibration, and related activities. Furthermore, the consequences for the TF management and sponsors during multisite studies are discussed, with particular regard to the existence of other responsibilities set forward by health authorities in countries with not negligible differences in the applicable regulations. Hence, the major question on the floor is whether one global set of GLP principles can be agreed upon which in turn can lead to one global submission file. It is firmly hoped that health authorities and industry, hand in hand, can actually optimize their interaction to the overall benefit of human health.
Johnson&Johnson, Beerse, Belgium. rhendrik@prdbe.jnj.com
Rik
R
Hendriks
Hilde
H
Van den Eynde
Werner
W
Coussement
D019411:Clinical Laboratory Techniques / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D012926:Social Control, Formal