Direct Links to important GMP Guidelines

ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology

This Guideline extends the guideline Q2A to include the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedures which are included as part of registration applications and describes the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures. The content of this guideline was previously included in two separate guidelines coded Q2A and Q2B, which were unified to the Q2(R1) guideline in November 2005.


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