International ISO Standard ISO15378 Primary packaging materials for Fourth edition medicinal products Particular 2017-09 requirements for the application of AMENDMENT 1 Is0 9001:2015, with reference to 2024-02 good manufacturing practice (GMP) AMENDMENT 1: Climate action changes Articles d'emballage primaire pour médicaments - Exigences particulieres pour I'application de I'ls0 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF) AMENDEMENT 1: Actions relatives aux changements climatiques Referencenumber IS0 15378:2017/Amd.1:2024(en) @ ISO 2024 IS0 15378:2017/Amd.1:2024(en) COPYRIGHT PROTECTED DOCUMENT IS02024 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 CP401·Ch.deBlandonnet8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland IS02024-Allrightsreserved i