推进疫苗生产的机构合规性和持续改进：2024年虚拟培训马拉松工具包

For VaccineManufacturing 12 SEPTEMBER–10 OCTOBER2023 Advancinginstitutionalcompliance .VirtualTraining Marathon kit2024 Advancinginstitutional compliance Advancing institutional compliance and continuous improvement in vaccine manufacturing: Virtual Training ISBN 978-92-4-011980-2 (electronic version)ISBN 978-92-4-011981-9 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https://creativecommons.org/licenses/by-nc- Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestionthat WHO endorses any specificorganization, products or services. The use of the WHO logo is not permitted. Ifyou adapt the work, then you must license your work under the same or equivalent Creative Commons licence. Ifyou create a translation of this work, you should add the following disclaimer along with the suggested citation: Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediationrules of theWorld Intellectual Property Organization(http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.Advancing institutional compliance and continuous improvement in vaccine manufacturing:Virtual Training Marathon kit 2024. Geneva: World Health Organization; 2025. Licence:CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, seehttps://www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such astables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and toobtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party- General disclaimers.The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country,territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions All reasonable precautions have been taken by WHO to verify the information contained in this publication.However, the published material is being distributed without warranty of any kind, either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be 3Cover image: 3 Photo credits: © WHO/Fanjan Combrink. Vials of the malaria vaccine. Contents Session 1.Bio-analytical method development and validation ICH Q2(R2) and ICH Q14 forbiologicals–Implementation and inspection-related considerations3 Acknowledgements This document was developed under the supervision of Dr Jicui Dong, Unit Head of the LocalProduction and Assistance Unit in the Regulation and Prequalification Department, WHO, Acknowledgements are also due to the following external expertsfor theirtechnicalcontributions:Mr Daniel Barreto (PharmQGlobal Consulting, LLC, United States of America),Dr Alain Kupferman (AKAM Pharmaceutical Design, Belgium), Mrs Tracy Moore (TM PharmaGroup Limited, United Kingdomof Great Britain and Northern Ireland), Mr Stephan Neumann(Boehringer Ingelheim, Germany), Mrs Tara Scherder (SynoloStats LLC, United States of The following from WHO reviewed and provided comments on this document: Dr Jicui Dongand Mr David Woo, Local Production and Assistance Unit, WHO. Thefourth cGMP Training Marathonwas organisedwith financial support from the Bill &Melinda Gates Foundationandthe European Commission.The contents of this publication Abbreviations Introduction Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in low-and middle-income countries (LMICs) face challenges to achieve quality in local production,such as the lack of an available manufacturing workforce trained in quality and understanding The Local Production and Assistance (LPA) Unit inthe Innovation and Emerging TechnologiesDepartment (IET), Access to Medicines and Health Products Division (MHP), WHO, supportsMember States (MS), particularlyLMICs, to strengthen sustainable local production andtechnology transfer(TT)to improve timely, equitable access to quality, safe and effectiveessential medical products. The LPA Unit provides assistance and su