Analysis of Guideline for General Requirements for Pharmaceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.04.002
- VernacularTitle:2025年版《中国药典》药包材通用要求指导原则解析
- Author:
Kai XU
1
;
Lei CHEN
;
Hui YU
;
Bo ZHANG
;
Yanping SHI
;
Min WAN
;
Chenghu LIU
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:
Chinese Pharmacopoeia;
pharmaceutical packaging materials and containers;
quality standards;
full lifecycle management;
risk management;
pharmaceutical packaging system
- From:
Drug Standards of China
2025;26(4):349-354
- CountryChina
- Language:Chinese
-
Abstract:
This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.
