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Standard
ISO 15378
Fourth edition
Primary packaging materials for
2017-09
medicinal products — Particular
requirements for the application of
AMENDMENT 1
ISO 9001:2015, with reference to
2024-02
good manufacturing practice (GMP)
AMENDMENT 1: Climate action
changes
Articles d'emballage primaire pour médicaments — Exigences
particulières pour l'application de l'ISO 9001:2015 prenant en
considération les Bonnes Pratiques de Fabrication (BPF)
AMENDEMENT 1: Actions relatives aux changements climatiques
Reference number
ISO 15378:2017/Amd.1:2024(en) © ISO 2024
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ISO 15378:2017/Amd.1:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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ISO 15378:2017/Amd.1:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial
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