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.
Tags
- Controlled temperature chain (CTC)
CTC_PUBLICATIONS
You can find more information about "CTC_PUBLICATIONS" in the following Hot Topics:
| Title | Author | Year | Type | Language |
|---|
| 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 | English, French |
| 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 | English, French |
| 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 | English, French |
| Delivering MenAfriVac using the controlled temperature chain approach | PATH, World Health Organization (WHO) | 2013 | Case study | English, French |
| 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 | English |
| How to monitor temperatures in the vaccine supply chain | UNICEF, World Health Organization (WHO) | 2015 | Guidance | English, French |
| 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 | English |
| Labelling Guidance for Controlled Temperature Chain (CTC) Qualification for Vaccine Manufacturers (2020) | World Health Organization (WHO) | 2020 | Guidance | English |
| Hepatitis B vaccines: WHO position paper - July 2017 | World Health Organization (WHO) | 2017 | Guidance | Arabic, Chinese, English, French, Russian, Spanish |
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Added on: 2023-11-30 17:19:52
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