Establishment And Application Of Quality Consistency Evaluation Mode Of TCM Products

Study objective: Globalization is the inevitable trend for traditional Chinesemedicines (TCMs). However, the most difficult issue for TCMs is how to assure thebatch to batch consistency and how could the quality standards be recognized byrelevant regulatory authorities. Currently, consensus has not been reached regardingthe confirmation of batch to batch consistency by the worldwide regulatory authorities.For this purpose, this paper proposes a TCMs quality consistency evaluation mode.Study method: The TCMs quality consistency evaluation mode has been establishedand optimized and further verified by case study and computer simulation study.Study result: Firstly, this paper has done differential analysis of the quality standardsof TCM products in China, US and the European Union. Secondly, the qualityconsistency evaluation mode of TCM products has been established and optimizedand further verified by case study and computer simulation study. Programmingmodel has also been established by computer software. Thirdly, comprehensivequality control standards mode for TCM raw material, drug substance and productwhich conforms to the regulation requirements of Europe and the US, the evaluationsystem for post-approval changes and TCM-equivalence have also been establishedbased on this TCM quality consistency evaluation mode. Lastly, hopefully this modecould be utilized to other TCM projects and proves to be a general principle of qualitycontrol standards and recognized by global regulatory authorities.Study conclusion: The advantage of this new mode is the evaluation parameters takeinto account the characteristics of TCMs and expressed by the meaning of moderntechnology. Compared with current evaluation method, this newly proposed modecould be even more strictly control the quality of TCM products and sensitive to thevariation of the quality of products.