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Q2B Validation of Analytical Procedures: Methodology May 1997

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document is complementary to the ICH guidance entitled Text on Validation of Analytical Procedures (ICH Q2A), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data that should be presented in a new drug application.

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All written comments should be identified with this document's docket number: FDA-1996-D-0169.

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