Use of ionizing radiation in the manufacture of medicinal products
This guideline applies to human and veterinary medicines.
|Current effective version|
|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.|