Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry Guidance for Industry September 2021
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
September 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1). This guidance consists of the previously published FDA guidances, Q2A and Q2B. It is the same, in substance, as those two guidances, and it is the same, in substance, as the November 2005 ICH Q2(R1) guideline.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6821.