PIC/S GMP草药药品生产附录与我国GMP中药饮片、中药制剂附录及相关法规的对比与思考

吴晶; 王晗; 孙文; 李娜; 杨希凡; 王琳

doi:10.16153/j.1002-7777.20240172

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中国药事 ›› 2024, Vol. 38 ›› Issue (12) : 1345-1350. DOI: 10.16153/j.1002-7777.20240172

监督管理

PIC/S GMP草药药品生产附录与我国GMP中药饮片、中药制剂附录及相关法规的对比与思考

吴晶, 王晗, 孙文, 李娜, 杨希凡, 王琳^*

作者信息 +

A Comparative Analysis and Reflection on the PIC/S GMP Annex for Herbal Medicinal Products Production with the Chinese GMP Appendices for Traditional Chinese Medicine Decoction Pieces and Preparations, and Related Regulations

Wu Jing, Wang Han, Sun Wen, Li Na, Yang Xifan, Wang Lin^*

Author information +

文章历史 +

摘要

目的： 通过对药品检查合作计划（PIC/S）GMP草药药品生产附录进行对比研究,查找我国中药生产相关法规的优势及不足,为顺利加入PIC/S提供理论依据。方法： 对我国GMP中药饮片、中药制剂附录及相关法规与PIC/S GMP草药药品生产附录的内容进行全面对比,并就一些优势和差异问题进行分析讨论。结果： 我国GMP中药饮片、中药制剂附录及相关法规与PIC/S GMP草药药品生产附录在各个方面要求基本一致,且我国中药监管法规在厂房与设施设备、人员、确认与验证、生产管理、质量控制等方面的要求较PIC/S GMP草药药品生产附录更全面、更具体。结论： 我国中药生产相关法规具备良好基础,已满足PIC/S GMP草药药品生产附录的要求,后续应坚定信心,明确方向,进一步完善我国中药生产相关法规要求。

Abstract

Objective: To identify the advantages and disadvantages of the regulations related to the production of traditional Chinese medicine (TCM) by conducting a benchmarking study on the annex of PIC/S GMP for herbal medicine production, and to provide a theoretical basis for China's smooth accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods: A comprehensive comparison was conducted among Chinese GMP decoction pieces, Chinese medicinal preparations annex, relevant regulations and the PIC/S GMP annex for Herbal Medicines production. An analysis and discussion were carried out on certain advantages and differences. Results: The requirements of China's GMP appendices for TCM decoction pieces and preparations, as well as related regulations, were essentially consistent with those of the PIC/S GMP annex for Herbal Medicines in all aspects. Moreover, China's TCM regulatory regulations were more comprehensive and specific in terms of plant and facilities and equipment, personnel, confirmation and verification, production management, and quality control and other requirements compared to the PIC/S GMP Herbal Medicines. Conclusion: China's relevant laws and regulations related to TCM production have a solid foundation and already meet the requirements of the PIC/S GMP annex for Herbal Medicines. Moving forward, it is essential to maintain confidence, clarify the direction, and further refine the regulatory requirements for TCM production in China.

导出引用

吴晶, 王晗, 孙文, 李娜, 杨希凡, 王琳. PIC/S GMP草药药品生产附录与我国GMP中药饮片、中药制剂附录及相关法规的对比与思考[J]. 中国药事, 2024, 38(12): 1345-1350 https://doi.org/10.16153/j.1002-7777.20240172

Wu Jing, Wang Han, Sun Wen, Li Na, Yang Xifan, Wang Lin. A Comparative Analysis and Reflection on the PIC/S GMP Annex for Herbal Medicinal Products Production with the Chinese GMP Appendices for Traditional Chinese Medicine Decoction Pieces and Preparations, and Related Regulations[J]. Chinese Pharmaceutical Affairs, 2024, 38(12): 1345-1350 https://doi.org/10.16153/j.1002-7777.20240172

中图分类号： R95

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