The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products


Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
FDA Guidance for Industry
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.

Go back

GMP Conferences by Topics