Learnaboutgmp Community

Acceptance Criteria

Dear all,

Let me know the acceptance criteria for Analytical Method Validation parameters (For Assay, Related Substances and Dissolution) as per ICH.

Thanks,
Veeru

Veeru,

You can go through ICH guideline Q2

Haresh H.Donda
Senior Scientist-Analytical Research

[quote=Haresh Donda]Veeru,

You can go through ICH guideline Q2

Haresh H.Donda
Senior Scientist-Analytical Research[/quote]

Dear new guideline is ICH Q2R1, but for limits better check USP 30 “method validation of compendial methods” infact it is based on ICH but it gives proper limits.