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All TermsStandards

ICH Guidelines

International standards for pharmaceutical method validation, stability, and impurity limits.

Definition

International Council for Harmonisation guidelines, globally recognized standards for pharmaceutical development, including analytical method validation (ICH Q2), stability testing (ICH Q1A), and impurity limits (ICH Q3).

Related Terms

Method Validation
Demonstrating that an analytical method is accurate, precise, and fit for purpose per ICH Q2.
cGMP
Current Good Manufacturing Practice — FDA regulations for pharmaceutical manufacturing.

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