How can Good Laboratory Practice be Introduced in a Test Facility?

Abstract

When the necessity arises for a test facility to introduce a formal quality system, a number of questions have to be answered before a reasonable decision about the most appropriate system can be made. One of the foremost considerations in this respect will be the nature of the studies which are to be conducted under this quality system, coupled with the question of the quality target. If this target consists of convincing the future sponsors of the precision, reproducibility and general quality of the data generated by the test facility, then the implementation of an ISO- or accreditation-based system could be better suited to the needs of this facility. If, on the other hand, the studies do require the conduct under the rules of GLP because they may be considered as safety-related and apt to be submitted to a Regulatory Authority, then this test facility would have no other choice than to adopt the GLP Principles as its quality system. The decision to implement the GLP Principles in the test facility may also be influenced by other considerations, of which the wishes of, or requests from, the prospective sponsors form an economically very important part. Additionally, the attitude of the national compliance monitoring authority with regard to the applicability of GLP in borderline cases might also be taken into account, and a discussion with the relevant authority about the possibility of being entered in the national monitoring program is certainly to be advised.