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GUIDANCE DOCUMENT

Q2 (R1) Validation of Analytical Procedures: Text and Methodology March 1995

Final

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

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

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

[Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined document Q2(R1). The contents of Q2A and Q2B posted below were not revised

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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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All comments should be identified with the title of the guidance.