Issue Date: August 18, 1999
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
This guidance document provides guidance on general principles for the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
Download the Guidance Document
