Experience thus far with use of Controlled Temperature Chain (CTC) vaccines indicates that a longer CTC duration may be more important than CTC qualification at a high temperature (e.g., above 40°C). Therefore, WHO currently recommends that vaccine manufacturers conduct CTC stability tests at both 37°C and 40°C and seek to extend the CTC duration for as many days as data supports beyond the current minimum of 3 days. Manufacturers should also engage in dialogue with WHO before stability testing for CTC qualification to discuss the programmatic need for CTC use of the particular vaccine, suitability of the test protocol, and minimum acceptable potency level for regulatory and WHO prequalification approvals. Manufacturers should also contact WHO after stability testing for CTC qualification to discuss the results and confirm labelling plans for the product insert prior to regulatory and WHO prequalification approvals.
Année de publication
2020
Catégories
- Chaîne d'approvisionnement
Organisations
- Organisation Mondiale de la Santé (OMS)
Mots-clés
- Controlled temperature chain (CTC)
Références sur le sujet
CTC_PUBLICATIONS
Titre | Auteur | Année | Type | Langue |
Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions, Annex 5, TRS No 999 | World Health Organization (WHO) | 2016 | Guidance | Anglais |
Comment contrôler la température dans la chaîne d'approvisionnement en vaccins | World Health Organization (WHO) | 2015 | Guidance | Français |
Controlled temperature chain for vaccination in low- and middle-income countries: a realist evidence synthesis | Christopher P. Seaman, Anna-Lea Kahn, Debra Kristensen, Robert Steinglass, Dijana Spasenoska, Nick Scott, Christopher Morgan | 2022 | Journal article | Anglais |
Delivering MenAfriVac using the controlled temperature chain approach | PATH, World Health Organization (WHO) | 2013 | Case study | Anglais, Français |
Hepatitis B vaccines: WHO position paper - July 2017 | World Health Organization (WHO) | 2017 | Guidance | Arabe, Chinois, Anglais, Français, Russe, Espagnol |
How to monitor temperatures in the vaccine supply chain | UNICEF, World Health Organization (WHO) | 2015 | Guidance | Anglais |
Labelling Guidance for Controlled Temperature Chain (CTC) Qualification for Vaccine Manufacturers (2020) | World Health Organization (WHO) | 2020 | Guidance | Anglais |
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns : adaptation guide and facilitators guide | World Health Organization (WHO) | 2013 | Guidance | Anglais |
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns : training module for organizing immunization sessions | World Health Organization (WHO) | 2013 | Training | Anglais |
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns: guidance for immunization programme decision-makers and managers | World Health Organization (WHO) | 2013 | Guidance | Anglais, Français |
Utilisation du MenAfriVac™ (vaccin contre la méningite A) en chaîne à température contrôlée (CTC) pendant les campagnes - Guide à l'intention des décideurs et des administrateurs des programmes de vaccination | World Health Organization (WHO) | 2013 | Guidance | Français |
Utilisation du MenAfriVac™ (vaccin contre la méningite A) en chaîne à température contrôlée (CTC) pendant les campagnes - Guide d'adaptation et guide du formateur | World Health Organization (WHO) | 2013 | Guidance | Français |
Utilisation du MenAfriVac™ (vaccin contre la méningite A) en chaîne à température contrôlée (CTC) pendant les campagnes - Module de formation pour l'organisation de séances de vaccination | World Health Organization (WHO) | 2013 | Training | Français |
Ajouté par: Moderator
Ajouté le: 2024-04-25 12:39:48
Consultations: 75