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FDA Guidance for Industry: Q2A Validation of Analytical Procedures

Origin/Publisher:

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Document Type:
FDA Guideline for Industry
Content:
This guideline identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation

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