中国药包材微生物检查方法及标准的合理性探讨

《国家药包材标准》2015年版收载了130个药包材标准,在保障药包材及药品质量安全方面发挥了重要作用。然而,随着中国药典2020年版的修订和对药包材微生物限度检查认识的不断提高,当前药包材标准中的5类29种微生物和无菌检查方法及限度标准的合理性存在一定问题。本文从药包材微生物标准的项目设置、检查方法等方面分析存在的问题,提出优化项目等7个方面的修订建议,探讨建立基于风险的药包材微生物检查方法及标准的可行性,以期为中国药包材微生物检查方法及标准体系的完善提供参考。

Discussion on the Rationality of Methods and Standards of Microbiological Examination for Pharmaceutical Packaging Materials in China

The National Standards for Pharmaceutical Packaging Materials 2015 edition contained 130 standards for pharmaceutical packaging materials, which played an important role in ensuring the quality and safety of pharmaceutical packaging materials and drugs. However, with the revision of the Chinese Pharmacopoeia 2020 edition and the continuous improvement of the understanding of the microbial limit testing of pharmaceutical packaging materials, there are certain rationality problems in the 29 microbiological examination methods in 5 categories pharmaceutical packaging material standards. This paper analyzes the existing problems from the aspects of project setting and methods of microbial standards for pharmaceutical packaging materials, puts forward 7 suggestions such as optimizing projects, and discusses the feasibility of establishing risk-based microbial inspection methods and standards for pharmaceutical packaging materials. In order to provide a reference for the improvement of the microbiological inspection methods and standard system of pharmaceutical packaging materials in China.