生物制品稳定性研究考虑因素及常见缺陷分析

Factors Considered And Common Defects Analysis Of Biological Products Stability Test

关键词:  生物制品  稳定性研究 质量标准  影响因素 检查缺陷

Key words:  biological product  stability test  quality standard  influencing factor  defects

摘要:

目的:生物制品与其他药品具有明显的区别,其本身具有复杂多变特点,对光线、温度等影响因素高度敏感,在满足普通药品稳定性有关要求的前提下,应更多的关注影响其质量的因素,本文旨在为生物制品的稳定性研究提供一定的参考与借鉴。结果与结论:生物制品在开展稳定性研究时关注影响其质量和有效期等的因素,结合其产品特点、结构特性、质量标准制定等情况,制定适合其产品稳定性考察的方案并有效执行,控制风险。

Abstract:

ABSTRACT OBJECTIVE:Studies on the stability of biological products are different from other drugs due to their complex and changeable characteristics and highly sensitive to light, temperature, and other influencing factors. On the premise of meeting the stability requirements of common drugs, more attention should be paid to the factors affecting its quality. The main objective of this paper is to provide some reference for the stability study of biological products. Results and Conclusions: The stability research of biological products should pay attention to the factors affecting their quality and expiration date. It is advisable to develop a plan suitable for its product stability inspection and implement it effectively to control risks based on its product characteristics, structural characteristics, and quality standards.