In-use stability testing of human medicinal products - Scientific guideline

This document provides guidance on the studies to be undertaken to define a in-use shelf life for multidose products.

Keywords: In use-stability, in-use shelf-life, stability data, multidose container

Current effective version

Note for guidance on in-use stability testing of human medicinal products

Adopted Reference Number: CPMP/QWP/2934/99 Legal effective date: 01/09/2001