Use of ionizing radiation in the manufacture of medicinal products

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconAdopted guideline

Reference number 3AQ4A
Published 01/12/1991
Effective from 01/07/1992
Keywords Ionising radiation, irradiation, sterilization
Description This document applies to the use of ionising radiation in the manufacture of medicinal products. It provides guidance on the administrative data to be included in the application. It also covers different aspects of manufacturing process and validation of the irradiation procedure.


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