Masterarbeit

"The quality of the active substance - A look at the different regulatory requirements"

Dr. Klaus Hohenleitner (2001)

The regulatory requirements of the quality for the active substances are in a very dynamic process of harmonisation.

The manufacturing process has to be described extensively, that means the starting materials and intermediates are to be specified and criteria for the release and reprocessing are to be set. Critical steps should be defined inclusive their influence on the quality of the final product.

Meanwhile the requirements of the active substance are comparable to those of the finished product.

The European Pharmacaopeia is an useful platform for agreements concerning apparatus, test procedures, reagents and standard substances. These agreements are very important, because they have a strong influence on the test results.. The permanent adaption to new synthesis routes and impurity profiles results in monographs with reirrelevant test extent for the single case.

The Common Technical Document offers a very individual possibility to define the quality of an active substance in context to the finished product.

The ICH quality guidelines contain accepted requirements for the different quality topics like stability testing, impurities, specifications and analytical validation.

The Variation procedures are necessary to adapt the marketing authorisation documents to the changes in manufacturing or testing of the active substance, but they must be simplified.

32 pages