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GUIDANCE DOCUMENT

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

Final
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)

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