Test and Reference Item Issues

It is especially in this area of activities, where a well devised set of forms should be available from the beginning, in order to ascertain the possibility of a coherent accounting of test item utilisation. 

During the conduct of the first studies, it will become apparent, which ones of the various parts that have to interplay with each other for the full GLP compliance, are indeed able to provide this interplay, and in which ones some need is apparent for changes and improvements. 

Conducting studies according to the rules GLP will be the final effort needed to place a test facility under the reahn of the GLP Principles. Indeed it is only after some studies have been planned, conducted, reported and archived that the GLP compliance of a test facility can conclusively be judged. Therefore, GLP Compliance Monitoring Authorities will in most cases insist on the presentation of some GLP-studies before a final judgement on the compliance of the respective test facility can be made. 

It will finally become evident in the execution of studies, their documented transparency, their reconstructability and thus, in summary, in their quality and integrity that GLP has indeed been successfirUy implemented. The final proof of the pudding lies then not in the eating, but in the successful survival of an official Compliance Monitoring inspection (see the next part). 

The best rules can be worthless if there is no control over the adherence to them. This is true for every legal regulation, and GLP certainly is no exception. A roadside board in an Egyptian town reads  

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