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.
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
ICH guidelines for the quality of biotechnology products with respect to the specification of new biotechnology substances. With this guideline concerning specifications for biotechnology products ICH (Japan, USA, EU) intends to define uniform standards for the specifications of biotechnology products.