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

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

Description:

The core tripartite harmonised ICH text (previously coded Q2A) was finalised (Step 4) in October 1994. This identifies 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.

The addendum tripartite harmonised ICH text (previously coded Q2B) was finalised (Step 4) in November 1996. It extends the guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures.

The addendum has been incorporated into the core guideline in November 2005.

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