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.