The Idea Behind GLP

The consequences for the scientific assessment of study validity did induce the European Medicines Evaluation Agency and its Committee for Proprietary Medicinal Products (EMEA/CPMP) to issue a draft guideline to deal with this problem of control sample contamination (CPMP, 2004). In this draft guideline reference is made to the GLP Principles and their requirement of fully, and truthfully, representing all results from a study, and the guideline stresses what is required for a GLP-compliant study report as follows The contamination of control samples with the test compound in toxicology studies shall be reported appropriately within a GLP statement as a deviation or violation. Contamination of controls should also be clearly acknowledged in the study reports and discussed by the Study Director with respect to its impact on the validity ofthe study.  

Any claim for the presence of certain advantageous properties, or for the absence of noxious influences, in an item which is publicly available or widely distributed, be this a car, a food or a chemical substance, can either be accepted in mutual trust, or it has to be verified by some mechanism. In some cases the importance of being able to rely absolutely on the claim made by the manufacturer or the distributor may not be so great as to necessitate or justify such a verification. Whether it is true that a certain make of car could be able to run at a speed of 300 km/h will not be important to most drivers in their 

All these requirements can be summarised in three issues that are central to the ideas behind GLP  

The second issue can be looked at as accountability and is very closely connected with the first one. The documentation needed in the GLP compliant conduct of a study will tell years later, who was doing what, and who could be held accountable for mistakes. On the other hand, if any question arises, it is also possible, because of this accountability, to call on the correct person, if still available at the test facility, the technician who actually did this piece of work, for clarification of this problem. Or, as another example, it makes it possible to look at the records accounting for amounts of test item received, used, and returned or destroyed at the end of the experiment in order to judge the plausibility of claims for doses given to animals or for concentrations used in field studies. 

AU of these points necessitate, however, that one general principle be foUowed, namely that not only records will be generated for each and every activity, event and condition, but that these records should be retained in such a way as to allow an orderly retrieval of each single piece of information whenever that might be needed. A test facility, or a study, in which such 

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