Objective To carry out a proficiency testing of content determination of geniposide in Gardeniae fructus, evaluate the content determination ability of index components in traditional Chinese medicine in the laboratory of inspection and detection in drug-related fields, and improve the quality control ability of content determination of related laboratories.

Methods The laboratory's capability-verification activities were conducted based on the CNAS-RL02 Rules for Proficiency Testing and ISO/IEC 17043 Conformity Assessment-General Requirements for Proficiency Testing. After preparing the sample, the results of homogeneity and stability tests were analyzed according to CNAS-GL003 Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing. After the test results were qualified, they were used as proficiency testing samples and randomly distributed to participants. The results were collected, and the robust statistical method and the Z scores were used to analyze the results of these laboratories' reports.

Results 403 laboratories in this proficiency testing program reported the results, of which 367 results were acceptable, accounting for 91.07%, 17 (4.22%) laboratories obtained suspicious results, and 19 laboratories gave unsatisfactory results, with the dissatisfaction rate of 4.71%.

Conclusion The majority of the 403 participant laboratories have the ability to determine the content of geniposide in Gardeniae fructus by HPLC and the laboratory testing ability and quality management level of the drug monitoring system are high. This proficiency testing provides a basis for understanding the technical reserve capacity and management level of China's pharmaceutical inspection and testing laboratories, and provides technical support for future government supervision.

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