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Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
Short Title:Q6B
Internet:http://www.fda.gov/cder/guidance/Q6Bfnl.PDF
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/cder/guidance/index.htm
Content:This guidance document provides guidance on general principles for the setting and justification of a uniform set of international specifications for biotechnological and biological products.
Document Type:FDA Guidance for Industry