Interpretation of Guideline for Rubber Closures for Pharmaceutical Packaging in the Chinese Pharmacopoeia(2025 Edition)
10.3870/j.issn.1004-0781.2024.11.009
- VernacularTitle:《中华人民共和国药典》(2025年版)药品包装用橡胶密封件指导原则解读
- Author:
Jun XU
1
;
Meicheng YANG
;
Lei CHEN
Author Information
1. 上海市食品药品包装材料测试所,上海 201203
- Keywords:
Pharmaceutical packaging;
Rubber closures;
Chinese Pharmacopoeia;
Guideline;
Interpretation
- From:
Herald of Medicine
2024;43(11):1754-1758
- CountryChina
- Language:Chinese
-
Abstract:
Objective To interpret the guideline for rubber closures for pharmaceutical packaging in the Chinese Pharmacopoeia(2025 Edition)for relative parties to facilitate their better understanding and reasonable application of the guideline.Methods Based on the considerations of lifecycle risk management and combined with the developing requirements for the quality management of rubber closures,the necessity of establishing the guideline was explained and the relevant contents of quality control were interpreted,and suggestions of the reasonable utilization of rubber closures were given.Results According to the rubber closures'properties and their actual application,relative parties should establish the enterprise standards or the quality agreements of the rubber closures,in line with the general baseline requirements settled by the guideline.Conclusion Based on the risk management concept in the whole process,the established guideline defining the quality control requirements of rubber closures and their critical quality attributes would be helpful to promote the quality control of rubber closures.
