橡胶类药包材国际标准概况及进展OACSTPCD

Rubber pharmaceutical packaging materials are essential components in drug packaging.This paper aims to investigate and analyze the overview of international standards for rubber pharmaceutical packaging materials,providing insights for the establishment and optimization of China's national standards system for rubber pharmaceutical packaging materials.Through a systematic review of the standard systems for rubber pharmaceutical packaging materials in various national pharmacopeias and industry standards,the standards for rubber in international standards such as the United States Pharmacopeia and the European Pharmacopoeia are discussed and analyzed.A comparative analysis is conducted to examine the interconnections and differences among these standards.This study summarized the standard formats,key points in quality control,and the latest developments in different rubber pharmaceutical packaging materials standards.Considering the characteristics and forms of international standards for rubber pharmaceutical packaging materials,recommendations are proposed based on the requirements for correlated assessments and the construction of national standards systems.These suggestions aim to contribute to the development and enhancement of China's pharmaceutical packaging materials standards,aligning with industry growth and regulatory demands.