Issue, Approval and Distribution

In this area test facility management has again to play a central role Test facility management is responsible for ensuring that appropriate and technically valid Standard Operating Procedures are established . Management does not have to write or to issue technically valid SOPs, as for this task it may simply not have the necessary expertise. In many cases a Study Director would be the most capable person for describing all the standard procedures to be 

This again documents the importance of separating the various responsibility levels and the respective tasks in the operations of a test facility. As much as the Quality Assurance personnel have to be independent of the studies the quality of which they have to assure, the persons approving SOPs should be different from those writing and utilising them. Therefore, a Study Director cannot be allowed to perform test facility management functions enabling him to approve his own SOPs. While this may not be a problem in 

The GLP Principles are considering it important that SOPs are immediately available . Only in this way can it be assured that there is at least the possibility for (study) personnel to consult SOPs immediately, should the need arise. If an employee would have to go to the other end of the building in order to look up some forgotten detail in the instruction for the procedure to be performed, he might just go ahead with the task as he thinks fit and not bother about the way prescribed in the SOP. Of course, the immediate availability does not guarantee that personnel would indeed consult the SOP at every single step of the activity. In performing really routine procedures the 

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