Zdrowie i gospodarka · 1.03.1995
International Conference on Harmonisation; Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability
The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Text on Validation of Analytical Procedures.'' This 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 is intended to present topics that should be considered during the validation of the analytical procedures included as part of registration applications for pharmaceuticals.