Where Can GLP be Profitably Applied

Nevertheless, there are a number of instances where test facilities could, or should, adhere to the principles of GLP. The most obvious case is the not so rare one of the test facility, where only very few studies are conducted according to GLP to the fullest extent most of the studies performed there would either not qualify as safety studies, or they would not be conducted to 

GLP because the sponsor did not ask for a GLP compliant study. Where there is no obvious need for the application of the full requirements of GLP, e.g. no need for a formal Quality Assurance audit of the final report, it would seem to make no sense to apply these special regulations and thus to add to the administrative burden with no rewards whatsoever. However, in such a test facility, it would be of the utmost importance that in all other respects studies would be performed as if they were conducted under GLP Apparatus should be maintained and calibrated according to the respective SOPs, test systems should be properly located and identified, test items should be characterised and labelled, SOPs should be available for all activities performed at this test facility, the studies should be conducted to the applicable SOPs, the respective raw data should be treated in a manner analogous to those in a GLP study, and all these activities should be properly documented and recorded. Only if the personnel of this test facility were not allowed to apply two different standards in doing their work will it be ensured that a real GLP study, if one is to be performed, will truly be in compliance with the GLP Principles. 

Good Laboratory Practice can thus work both ways It might be used to detect fraud, but it could also serve to protect the researcher from unfounded allegations. In this sense, the implementation of the basic rules of GLP could be of benefit even (or especially) to a research institution or laboratory. 

Another example for the possibilities offered through the application of GLP in the research environment might be a somewhat more complex one. 

The writing of some such kind of a study plan before initiating the respective investigations would not only improve the reconstructability of the studies conducted. Already the process itself of writing-up the various aspects of the premeditated study would serve the Study Director to clarify in his or her mind the relative value of the different ways to achieve the purpose of the research project and thus to set out in a logical manner all the possibilities for proceeding to this end. 

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