What is Good Laboratory Practice All About ?

Abstract

Good Laboratory Practice belongs to the ever increasing number of “Good Practices”, starting with the Good Agricultural Practice and ending (probably) with the Good Zoological Practice. In many of these instances, the term “Good Practice” denotes nothing else than the established way of doing something, the way generally recognised as being the proper one. In many of these instances of “Good Practices” there are no “strings attached”, i.e. no specific rules are strictly to be followed in order to comply with the respective Good Practice. The area, where Good Laboratory Practice is employed, however, is of such importance, that the conduct of activities under its terms has to follow stricter rules than are recommended or prescribed in other areas of Good Practices. The difference to many of these other Good Practices, that most clearly separates Good Laboratory Practice from them, is that compliance to the rules of Good Laboratory Practice is of fundamental importance and necessity in the area of investigations into the safety of commercial (chemical) products. Another difference is that compliance to the Principles of Good Laboratory Practice, in company of only a few other “Good Practices”, notably those strongly connected with the field of pharmaceutical manufacturing and testing, is monitored by governmental, regulatory bodies. In contrast to this, Good Agricultural Practice, e.g., is just a notion used to set pesticide residue limits. It only describes the recommended farming practice, and, if a farmer is adhering in his spraying programme to the recommended dosage, to the recommended spraying intervals and to the recommended preharvest interval, he is using “GAP”, even if there were the possibility of using less active ingredient per area, or of using longer intervals between sprayings than recommended. The pesticide levels arrived at in this fashion in field trials will also subsequently be considered as residue limits.