Reflections on manufacturer′s reference materials of preventive human vaccines
10.13200/j.cnki.cjb.000085
- VernacularTitle:关于预防性人用疫苗企业标准物质的思考
- Author:
WANG Yiping
- Publication Type:Journal Article
- Keywords:
Vaccines;
Standards;
References;
Working reference materials
- From:
Chinese Journal of Biologicals
2023;36(12):1409-1413+1418
- CountryChina
- Language:Chinese
-
Abstract:
Reference materials for vaccine are the standard rulers for quality control,dose determination and effectiveness evaluation of vaccines. Manufacturer's reference materials are a kind of the working standards that are directly used by vaccine enterprises in the process of production,quality control and evaluation,of which the accuracy and stability play a key role in ensuring the consistency between batches,safety and effectiveness of vaccines. Based on the investigation into the current management situation of manufacturer's reference materials in domestic representative vaccine enterprises,and combined with the relevant guidelines and regulations such as World Health Organization guidelines and Chinese Pharmacopoeia,this paper put forward the key points that should be considered in the establishment and application of manufacturer's reference materials of preventive human vaccines. It is also suggested to formulate the guidelines about manufacturer's reference materials in order to regulate the development and application of working reference materials.
