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GUIDANCE DOCUMENT

Q2A Text on Validation of Analytical Procedures March 1995

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1994-D-0401
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan and the United States. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the European Union, Japan and the United States.

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All written comments should be identified with this document's docket number: FDA-1994-D-0401.

 
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