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What is ASEAN Analytical Procedure Validation Guide about?

This document provides guidelines for validating analytical procedures for submission as part of registration applications within ASEAN. It adopts two ICH guidelines on validation of analytical methods and notes that methodology may differ for biological products. The guidelines describe types of analytical procedures that should be validated including identification tests, quantitative impurity tests, limit tests, and quantitative active moiety assays. Key criteria for validation are described including pr

Author

Juliana 叶惠琴

Language

EN