Use of ionizing radiation in the manufacture of medicinal products

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference number3AQ4A
Published01/12/1991
Effective from01/07/1992
KeywordsIonising radiation, irradiation, sterilization
DescriptionThis 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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