Sterilisation of the medicinal product, active substance, excipient and primary container - Scientific guideline
Table of contents
Guidance is provided on the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur.) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative. Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers in a new marketing authorisation application or a variation application for a medicinal product.
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).
This guideline applies to human and veterinary medicines.
Keywords: Active substance, aseptic processing, container, decision trees, excipients, filtration, finished dosage form, sterilisation, sterilisation assurance level, terminal sterilisation, post-aseptic processing terminal heat treatment
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Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (PDF/234.47 KB)
Adopted
First published: 08/03/2019
Legal effective date: 01/10/2019
EMA/CHMP/CVMP/QWP/850374/2015 -
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Overview of comments received on the ‘Draft guideline on the sterilisation of the medicinal product, active substance, excipients and primary container' (PDF/1.72 MB)
First published: 08/03/2019
Last updated: 15/01/2020
EMA/CHMP/CVMP/QWP/366428/2018 (v.3.11) -
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Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (PDF/641.59 KB)
Draft: consultation closed
First published: 13/04/2016
Last updated: 13/04/2016
Consultation dates: 13/04/2016 to 13/10/2016
EMA/CHMP/CVMP/QWP/BWP/850374/2015 -
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Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products (PDF/97.73 KB)
Draft: consultation closed
First published: 09/04/2014
Last updated: 09/04/2014
Consultation dates: 09/04/2014 to 09/07/2014
EMA/CHMP/CVMP/QWP/128000/2014 -
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Superseded annex to note for guidance on development pharmaceutics: Decision trees for the selection of sterilisation methods (PDF/43.3 KB)
Adopted
First published: 05/04/2000
Last updated: 05/04/2000
CPMP/QWP/054/98
Effective from 01/08/1999 – 01/10/2019
Effective from 01/09/2000 – 01/10/2019
Effective from 01/04/2001 – 01/10/2019
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Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products (PDF/25.94 KB)
Adopted
First published: 29/03/2001
Last updated: 29/03/2001
Legal effective date: 01/04/2001
CPMP/QWP/159/01 -
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Concept paper on a proposal to limit the applicability of the CPMP/CVMP Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products to veterinary medicinal products - Superseded (PDF/77.08 KB)
Adopted
First published: 19/11/2015
Last updated: 19/11/2015
EMA/CHMP/SWP/211900/2015