制定药品、疫苗和体外诊断的质量规范：2024年质量培训包周

Week of Quality 2024training kit Drivingqualityacross the productlifecycle formedicines, vaccines,biotherapeutic products,and invitro diagnostics Week of Quality 2024training kit Driving quality across the product lifecycle for medicines, vaccines, biotherapeutic products, and in vitrodiagnostics: week of Quality 2024 training kit ISBN 978-92-4-011673-3 (electronic version)ISBN 978-92-4-011674-0 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike3.0 IGO licence (CC BY-NC-SA 3.0 IGO). 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:“This translation was not created by the World Health Organization (WHO). WHO is not responsible for the contentor accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licenceshall be conducted in accordance with the mediationrules of the World Intellectual Property Organization(http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.Driving quality across the product lifecycle for medicines, vaccines, biotherapeutic products,and in vitro diagnostics: week of Quality 2024 training kit. Geneva: World Health Organization; 2025. Licence:CCBY-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. Tosubmit 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 as tables,figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtainpermission from the copyright holder. Therisk of claims resulting from infringement of any third-party-ownedcomponent in the work rests solely with the user. 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 anddashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by WHOin preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHOto verify the information contained in this publication.However, the published material is being distributed without warranty of any kind, either expressed or implied. Theresponsibility for the interpretation and use of the material lies with the reader.In no event shall WHObe liable fordamages arising from its use. Photo credits: ©Shutterstock/Numstocker, Flu vaccine vial dose, drug injection, needle syringe.Photo credits: © iStock/Vieriu Adrian,Rapid Strep Test RST kit.Photo credits: ©iStock/Mykhailo Tamakhin, Range of medications and drugs. Contents Acknowledgements…………………………………………………………………………………………………………………………………..Abbreviations……………………………………………………………………………………………………………………………………………Introduction………………………………………………………………………………………………………………………………………………ivv1 Session 1-Core elements of compliant performance evaluation……………………………………………………………………………….Session2-Building “quality by design” into clinical performance studies………………………………………………………………....Session 3: Usability: a critical step towards true quality……………………………………………………………………………………………..Session 4: IVD software excellence: streamlining validationandverification…………………………………………………………....Session 5: Improving the quality of instructions for use: content, process and tools………………………………………………….Session 6: Enhancing quality, safety, and efficacy in the production of IVD analyzers………………………………………………..Session 7: Leveraging post-market surveillance data for product quality improvement……………………………………………..Session 8: Increasing the likehood of attaining “quality-assured” status for IVDs……………………………………………………...389921263135 Driving pharmaceutical product development forward by navigating quality requirements………………