Analysis of the Construction Approach of the Prefilled Syringe Standard System in Chinese Pharmacopoeia

VernacularTitle:《中华人民共和国药典》预灌封注射器标准体系的构建思路解析
Author: Yong SHEN ¹ ; Xiaowen BO ; Xiaohui YU ; Hui YU ; Lei CHEN
Author Information

1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101
Publication Type:Journal Article
Keywords: Prefilled syringe; Subassembled prefilled syringe; Standard system; Quality attributes
From: Herald of Medicine 2025;44(4):523-527
CountryChina
Language:Chinese
Abstract: Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis.Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards;the critical quality attributes of pre-filled syringe container systems were identified.Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China.Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility,meeting regulatory needs and facilitating industry development.