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A Comparative Study on the Lot Release Systems for Vaccines as of 2016
Kentaro Fujita1, Seishiro Naito1, Masaki Ochiai1
1Department of Quality Assurance and Radiological Protection, National Institute of Infectious Diseases.
Japanese Journal of Infectious Diseases
|July 5, 2017
Summary
Regulatory authorities worldwide use diverse vaccine lot release systems. This study highlights variations in testing policies and items, emphasizing the need for global harmonization to ensure vaccine quality.
Area of Science:
- Vaccinology
- Regulatory Science
- Public Health
Background:
- National regulatory authorities (NRAs) implement country-specific vaccine lot release systems.
- The World Health Organization (WHO) advocates for harmonizing these systems to ensure global vaccine quality assurance.
Purpose of the Study:
- To investigate and compare vaccine lot release systems across different countries and regions.
- To identify common practices and areas of diversity in vaccine lot release policies.
Main Methods:
- A questionnaire-based investigation was conducted.
- Data were collected from 7 countries and 2 regions regarding their vaccine lot release procedures.
Main Results:
- Review of summary protocols by NRAs is a common practice for independent vaccine lot release.
- Significant diversity exists in testing policies, including the frequency of testing (e.g., routine vs. risk-based) and selected test items.
- Potency tests were prioritized across most investigated lot release systems.
Conclusions:
- Understanding the current landscape of vaccine lot release policies is crucial for future improvements.
- Harmonizing vaccine lot release systems globally can enhance the consistent provision of high-quality vaccines worldwide.
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