Guidelines ICH

• Q2A : Text on Validations of Analytical Procedures
  Implementation (Step 5):
     EU: Adopted by CPMP, December 96, issued as CPMP/ICH281/95
     MHLW: Adopted October 97, PMSB/ELD Notification No.338
     FDA : Published in the Federal Register, Vol. 62, No. 96, May 19, 1997, pages  27463-27467
• Q2B : Methodology
  Implementation (Step 5):
     EU: Adopted by CPMP, December 96, issued as CPMP/ICH281/95
     MHLW: Adopted October 97, PMSB/ELD Notification No.338
     FDA: Published in the Federal Register, Vol. 62, No. 96, May 19, 1997, pages      27463-27467

Guidelines EUDRALEX

• 3AQ13A : Validation of Analytical Procedures: Methodology
• 3AQ14A : Validation of Analytical Procedures: Definition and Terminology

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Jean Cumps - Faculé de Médecine UCL - Ecole de Pharmacie - TPAO