The Major Task Standard Operating Procedures

Well prepared with lists of study types, test systems, and apparatus to be used in the future GLP compliant test facility, the task of writing the various SOPs can now be tackled in earnest. 

It might be easiest to start with the SOPs in the area of apparatus, instruments and equipment. On the one hand, the manuals and directions for use which are normally provided by the manufacturer or the vendor can either be utilised as templates for the description of the standard way to use them, or 

The computerised systems will certainly occupy a major part of the brain power for the implementation of GLP also in the SOP area. Since it may not be assumed that in the era before GLP very extensive thoughts had been spent on the validation of computerised systems, especially those hidden in purchased standard apparatus, the compilation of a list of apparatus containing electronic devices and functionalities, and their prioritisation in terms of validation necessity should also be contemplated at this point. 

There are different ways to come to grips with the problem of complete -or as complete as complete can be - SOP coverage. The solitary thinker might lock himself up and devise logically the way certain studies are being conducted and the areas where specific SOPs would be needed. More sociable 

A further area which has to be dealt is the generation of all sorts of forms to be used in various areas of test facility activities. Since these forms do not need any kind of approval, they may be composed and produced on an as-needed basis. While such a (maybe rather chaotic) approach can certainly be applied, it might nevertheless be preferable for the first round of implementation efforts to try to develop also these forms in a coherent way. 

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