南部非洲发展共同体注册催产素的保质期和储存条件评估

Regulatory requirements, policies and practicesfor cold chain reproductive medicinesRegulatory requirements, policies and practicesin countries for storage conditions and shelf life ofcold chain reproductive health medicines Assessment of shelf life and storageconditions of registered oxytocin inthe Southern African DevelopmentCommunity Regulatory requirements, policies and practicesin countries for storage conditions and shelf life ofcold chain reproductive health medicines Assessment of shelf life and storage conditions of registered oxytocin in the Southern African DevelopmentCommunity: regulatory requirements, policies and practices in countries for storage conditions and shelf life of coldchain reproductive health medicines ISBN 978-92-4-011166-0 (electronic version)ISBN 978-92-4-011167-7 (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; https://creativecommons.org/licenses/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 specific organization, products or services. The use of the WHO logo is not permitted. If youadapt the work, then you must license your work under the same or equivalent Creative Commons licence. If youcreate a translation of this work, you should add the following disclaimer along with the suggested citation:“Thistranslation was not created by the World Health Organization (WHO). WHO is not responsible for the content oraccuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediationrules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. Assessment of shelf life and storage conditions of registered oxytocin in the Southern AfricanDevelopment Community : regulatory requirements, policies and practices in countries for storage conditions andshelf life of cold chain reproductive health medicines. Geneva: World Health Organization; 2025. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.CIP data are available at https://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, see https://www.who.int/publications/book-orders. Tosubmit requests for commercial use and queries on rights and licensing, see https://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. The risk 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 endorsedor recommended by WHO in 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 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. Theresponsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable fordamages arising from its use. Contents Abbreviations and acronymsv Executive summaryvi 1.Introduction1 11 Problem statement212 Objectives2 21 Study area322 Study design323 Study population324 Sampling method and sample size325 Data collection326 Ethical considerations4 3.Results5 31 Institutional details532 Response rate533 Description of quality reviewers in the national regulatory authorities534 Policies/guidelines for assigning storage conditions and shelf life of medicines535 Practices and key issues in assigning storage conditions and shelf life536 Key considerations when assigning storage conditions and shelf life537 Requirements for conducting stability testing638 Considerations for approving storage conditions and shelf life and their importance639 Analysis of registered oxyto