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 Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products


Document Type:
ICH Guideline
This guideline forms an annex to the main ICH Stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products, in which the active components are typically proteins and/or polypeptides.

Go back

GMP Conferences by Topics