Interpretation of the Standards for Plastic Composite Tube System and Components for External Ointment in the Pharmacopoeia of the People's Republic of China(2025 Edition)
10.3870/j.issn.1004-0781.2025.07.011
- VernacularTitle:2025年版《中华人民共和国药典》外用软膏剂用塑料复合管系统及组件标准解读
- Author:
Yun TANG
1
;
Zhenxi XU
;
Weiyi LU
Author Information
1. 江苏省医疗器械检验所化学性能检验室,南京 210019
- Publication Type:Journal Article
- Keywords:
The plastic composite tube system and components for external ointments;
the Pharmacopoeia of the People's Republic of China(2025 edition);
Interpretation
- From:
Herald of Medicine
2025;44(7):1073-1078
- CountryChina
- Language:Chinese
-
Abstract:
To further interpret the 2025 edition of the Pharmacopoeia of the People's Republic of China for plastic composite tube system and components for external ointment,and to provide help for the understanding and implementation of the standard,this article gave an in-depth interpretation of the standard from three aspects:industry status,domestic and foreign standards,and the relevant requirements of the 2025 edition of the Chinese Pharmacopoeia.Specific toxic substances and raw material requirements were discussed.The standard adheres to the concept of source control and whole life cycle risk management,and provided a comprehensive basis and guidance for enterprises from the aspects of production,use,and category key quality attributes,from raw material selection,process optimization,to product quality control.The standard effectively controls product risks and key quality attributes,while taking into account product diversity and innovation requirements,reflected the unity of effective risk control and flexibility,and played a positive role in promoting product safety and industry innovation and development.
