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The following article starts with an overview of the current FDA regulations concerning the validation of analytical methods, including current draft guidances relevant to validation. Prerequisites for validation, the content of method descriptions, basic thoughts about statistics, the meaning of raw data as well as principles for a validation protocol and a validation report are presented under ’fundamental requirements’.
The relevant quality attributes of analytical methods are described and connected with the different types of analytical methods. The fundamental principles are completed by advice on setting acceptance criteria as well as by an overview of methods available for validation studies.
In the second part, the meaning, the basic requirements of the regulations and the procedures in conformity with the regulations are described for each validation parameter.
This review is rounded off by instructions for combination experiments and development projects, which are useful for reducing the required laboratory capacity.

Key words Arzneimittel-Analytik • FDA • ICH • Methodenvalidierung Qualitätskontrolle