Use of ionizing radiation in the manufacture of medicinal products - Scientific guideline

This guideline applies to human and veterinary medicines.

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.

Keywords: Ionising radiation, irradiation, sterilization

Current effective version

The use of ionising radiation in the manufacture of medicinal products

AdoptedReference Number: 3AQ4ALegal effective date: 01/07/1992