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

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

https://www.gmp-compliance.org/files/guidemgr/3-1-14.pdf

Origin/Publisher:

Document Type:
ICH Guideline
Content:
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.

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