Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

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

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