Guidance

Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions, Annex 5, TRS No 999

Vaccines are complex biological products and may undergo degradation during long-term storage under cold chain conditions (for example, 2–8 °C) and this is typically enhanced at higher temperatures. Consequently, establishing the stability characteristics of products is a critical element of the overall evaluation by a national regulatory authority (NRA) to ensure that licensed vaccines remain efficacious at the end of their shelf-life when stored under the approved conditions. In response to the stability assessment needs identified by NRAs, WHO developed guidelines on the stability evaluation of vaccines to assist its Member States.

Languages

  • English

Publication year

2016

Type

Guidance

Categories

  • Supply chain & logistics

Tags

  • CTC

Topic references

CTC_PUBLICATIONS

TitleAuthorYearTypeLanguage
Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions, Annex 5, TRS No 999World Health Organization (WHO)2016GuidanceEnglish
Comment contrôler la température dans la chaîne d'approvisionnement en vaccinsWorld Health Organization (WHO)2015GuidanceFrench
Controlled temperature chain for vaccination in low- and middle-income countries: a realist evidence synthesisChristopher P. Seaman, Anna-Lea Kahn, Debra Kristensen, Robert Steinglass, Dijana Spasenoska, Nick Scott, Christopher Morgan2022Journal articleEnglish
Delivering MenAfriVac using the controlled temperature chain approachPATH, World Health Organization (WHO)2013Case studyEnglish, French
How to monitor temperatures in the vaccine supply chainUNICEF, World Health Organization (WHO)2015GuidanceEnglish
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns : adaptation guide and facilitators guideWorld Health Organization (WHO)2013GuidanceEnglish
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns : training module for organizing immunization sessionsWorld Health Organization (WHO)2013TrainingEnglish
Use of MenAfriVac™ (meningitis A vaccine) in a controlled temperature chain (CTC) during campaigns: guidance for immunization programme decision-makers and managersWorld Health Organization (WHO)2013GuidanceEnglish, French
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 vaccinationWorld Health Organization (WHO)2013GuidanceFrench
Utilisation du MenAfriVac™ (vaccin contre la méningite A) en chaîne à température contrôlée (CTC) pendant les campagnes - Guide d'adaptation et guide du formateurWorld Health Organization (WHO)2013GuidanceFrench
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 vaccinationWorld Health Organization (WHO)2013TrainingFrench

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Added on: 2023-11-30 17:19:52

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