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

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

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This document augments the stability guideline (Q1A above) 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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