Sterilisation of the medicinal product, active substance, excipient and primary container

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This guideline applies to human and veterinary medicines.

Current version

Draft guideline

Reference numberEMA/CHMP/CVMP/QWP/BWP/850374/2015
Published13/04/2016
Effective from 
KeywordsActive substance, aseptic processing, container, decision trees, excipients, filtration, finished dosage form, sterilisation, sterilisation assurance level, terminal sterilisation
DescriptionThis document provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, and the selection of appropriate methods of sterilisation for sterile products. This guideline replaces the previous annexes to Pharmaceutical development Decision trees for the selection of sterilisation methods, (human and veterinary). It also revises the information on methods of sterilisation previously described in the note for guidance on manufacture of the finished dosage form (human and veterinary).


Document history

First version

Current version

Draft guideline


Concept paper

Published: 13/04/2014


Published: 09/04/2014


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