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CEN

EN ISO 15378:2017/prA1

(Amendment)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) - Änderung 1: Ergänzung zu klimabezogenen Maßnahmen (ISO 15378:2017/Amd 1:2024)

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 (ISO 15378:2017/Amd 1:2024)

Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) - Dopolnilo 1: Upoštevanje podnebnih sprememb (ISO 15378:2017/Amd 1:2024)

General Information

Status
Not Published
Publication Date
04-Nov-2025
ICS
03.100.70 - Management systems
11.040.01 - Medical equipment in general
Technical Committee
CEN/SS F20 - Quality assurance
Current Stage
Ref Project
SIST EN ISO 15378:2018/oprA1:2024 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

Relations

Amends
EN ISO 15378:2017 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Effective Date
22-Nov-2023

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SLOVENSKI STANDARD
SIST EN ISO 15378:2018/oprA1:2024
01-maj-2024
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO
9001:2015 v povezavi z dobro proizvodno prakso (DPP) - Dopolnilo 1: Upoštevanje
podnebnih sprememb (ISO 15378:2017/Amd 1:2024)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP) -
Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) - Änderung 1:
Ergänzung zu klimabezogenen Maßnahmen (ISO 15378:2017/Amd 1:2024)
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 (ISO
15378:2017/Amd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 15378:2017/prA1
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
SIST EN ISO 15378:2018/oprA1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 15378:2018/oprA1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 15378:2018/oprA1:2024
International
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

---------------------- Page: 3 ----------------------
SIST EN ISO 15378:2018/oprA1:2024
ISO 15378:2017/Amd.1:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland

© ISO 2024 – All rights reserved
ii

---------------------- Page: 4 ----------------------
SIST EN ISO 15378:2018/oprA1:2024
ISO 15378:2017/Amd.1:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide feder
...

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