Zdrowie i gospodarka · 19.05.1997
International Conference on Harmonisation; Guideline on the Validation of Analytical Procedures: Methodology; Availability
The Food and Drug Administration (FDA) is publishing a guideline entitled, ``Validation of Analytical Procedures: Methodology.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline provides recommendations on how to consider various validation characteristics for each analytical procedure. The guideline is an extension to the ICH guideline entitled, ``Text on Validation of Analytical Procedures.''