ISO INTERNATIONAL STANDARD 18362 First edition 2016-02-01 Manufacture of cell-based health care products - Control of microbial risks during processing Manufacture de produits de soins de sante fondes sur les cellules - Controle des risques microbiaux durant le processus Reference number ISO 18362:2016(E) ISO International Organization for Standardization @ IS0 2016 ZHEJIANG INST OF STANDARDIZATION C15956617 vided by IHS under itted without license from IHS IS0 18362:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS02016,PublishedinSwitzerland All rights reserved. Unless otherwise specified, 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. ISOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Intenationaibr PrganizationforStandardization icensee-ZHEJIANG INST OF STANDARDIZoISQ s.6 - All rights reserved Not for Resale, 2016/3/29 02:50:08 etworking permitted without license from IHS IS0 18362:2016(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope 2 Normative references 3 Terms and definitions 4 Quality system elements 5 Process definition .5 5.1 General. .5 5.2 Risk management. 5.2.1 General considerations .6 5.2.2 Cell-based starting material risk assessment 5.2.3 CBHP process risk assessment. ..7 5.2.4 Use of risk assessment methods and tools for supply of CBHPs for use in clinical trials ..8 6 Manufacturing environment. 6.1 General 6.2 Alternative processes ..8 6.3 Manufacturing environment design ..8 6.3.1 Containment area. ..8 6.3.2 Construction containment features .8 6.4 Layout .9 6.5 Material and personnel flow .9 6.5.1 General 6.5.2 Equipment .9 6.5.3 Handling of waste material 6.6 HVAC system. .10 6.7 Utility services and ancillary equipment. .10 6.8 Environmental and personnel monitoring programmes ..10 7 Equipment. .10 7.1 General ..10 7.2 Additional requirements ..10 8 Personnel. .11 8.1 General. ..11 8.2 Personnel procedures .11 8.3 Gowning procedures .11 8.4 General employee health .11 9 Manufacture of product .12 9.1 General .12 9.2 Control of starting material ..12 9.2.1 Cell-based starting material .12 9.2.2 Other starting materials ..12 9.3 Manufacturing procedures. .13 9.4 In-process controls and process monitoring ..13 9.5 Viruseliminationandinactivation ..13 10 Process simulation and process confirmation ..13 10.1 General ..13 10.2 Process simulation.. ..14 10.3 Process confirmation studies. .14 10.4 Media selection and growth support ..14 11 Finished product release: test for sterility ..15 ntemaonalganizatinAll rights reserved iii nsee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ed without license from IHS Not for Resale, 2016/3/29 02:50:08