Interpretation of the management guidelines for quality agreements of pharmaceutical packaging materials under the new situation

VernacularTitle:新形势下药包材质量协议管理指南解读
Author: Mingxia GU ¹ ; Lei CHEN ; Hong CAI ; Yonghua GAO ; Hong JIN ; Xiao HAN ; Ruiling HE
Author Information

1. 中国医药包装协会,北京 100803;无锡药明生物技术有限公司,江苏无锡 214100
Publication Type:Journal Article
Keywords: pharmaceutical packaging materials; quality agreement; Chinese Pharmacopoeia; Good Manufacturing Practice for Drugs
From: Drug Standards of China 2025;26(4):355-358
CountryChina
Language:Chinese
Abstract: Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.