The principles of Good Laboratory Practice (GLP) are designed to help ensure the proper management and conduct of studies. GLP compliance demonstrates to regulatory authorities that studies were undertaken in a manner which promotes confidence in the data and reporting. Formal validation of in vitro toxicity studies is being recommended as an inter-laboratory activity. Study management of interlaboratory studies in compliance with GLP is discussed. This includes: a) a clearly defined management, with responsibility for the GLP compliance of participating laboratories; b) one Study Director, who represents the single point of study control and who overviews study procedures and data, to ensure that procedures laid down in the protocol are being followed; and c) Principal Investigators, who may be appointed at some, or all, of the participating laboratories to facilitate supervision and communications with the Study Director.
