Reflections on quality control materials for vaccine quality control and clinical trial sample detection
10.13200/j.cnki.cjb.004656
- VernacularTitle:疫苗质控和临床研究样本检测质控品的思考
- Author:
Xuanxuan ZHANG
1
Author Information
1. National Institutes for Food and Drug Control, Beijing 102629, China
- Publication Type:Journal Article
- Keywords:
Quality control materials;
Reference reagents;
Reference materials;
Quality control rules
- From:
Chinese Journal of Biologicals
2026;39(02):243-250
- CountryChina
- Language:Chinese
-
Abstract:
Quality control materials are crucial for assessing the validity and consistency of vaccine quality control and laboratory test results. Given the particularity of vaccine products and clinical samples, the World Health Organization(WHO) and China have issued several reference reagents and reference materials for laboratory quality control to ensure the quality of testing. In recent years, national laboratory accreditation technical documents and national technical standards have been updated and improved to enhance laboratory quality control management. This includes technical requirements for the establishment, application, and quality control rules of quality control materials. The guideline for the design, establishment, and validation of biological activity assays in the Chinese Pharmacopeia(VolumeⅣ, 2025 edition) requires continuous monitoring of the activity of quality control materials in biological activity assays. Based on the characteristics of vaccine quality control and evaluation laboratories, targeted research and application of quality control materials and quality control rules are of practical significance for improving the quality control level of vaccines and the detection level of vaccine clinical trials in China. This paper reviews and summarizes domestic and international technical guidelines and literature related to quality control materials, aiming to provide insights and recommendations for developing, establishing, and applying quality control materials in vaccine quality control and clinical sample testing.
