Interlude Personnel documentation

One of the various templates that will have to be created in the course of the implementation of GLP in a test facility are the templates for the personnel. While curricula vitae may differ in format (and anyway in content), the job descriptions should obtain a common format. Furthermore, training record forms have to be created, which will provide evidence for the fact that training of the individual has been up-to-date, not only in respect of his or her technical abilities, but also with regard to the training in, and understanding of, GLP matters in general and especially those relevant to the actual work to be performed. 

Under GLP a number of special positions with special responsibilities have to be created. Although some of these positions may already be present in a test facility, they merit very thorough reflection and consideration at this point. The responsibility of test facility management to assume the leading role in the implementation of GLP has already been described, as has the early appointment of a Quality Assurance manager or expert. There are the prospective Study Directors to be chosen, since they will have their central responsibility in the conduct of the studies, and thus they will have to have time to acquaint themselves with their new roles and responsibilities. 

Another organisational task will be the development of the test and 

The implementation of GLP has to be connected very early on with the distribution of the various responsibilities. Certain tasks require somebody to be in absolute control over their initiation, development, implementation and conclusion. Where the (external or part-time) Quality Assurance expert may not provide for sufficient co-ordination between the various issues to be tackled, then somebody should be nominated for this function, and should be made responsible for the orderly development of GLP implementation. 

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