中药共线生产的风险评估和清洁验证

Risk assessment and cleaning verification of collinear production of traditional Chinese medicine

多品种共线是药品生产普遍存在的情况,多产品共线的污染、交叉污染控制是药品生产质量管理规范检查中重点关注内容。中药品种间共线生产较普遍,且由于中药成分复杂、作用机制不明确、微量成分定量困难等原因,使中药品种共线生产的风险评估和清洁验证的考量点更复杂。归纳了中药共线生产和清洁验证存在的问题,探讨中药共线生产和清洁验证的主要考量点,并进行了中药共线生产清洁风险评估,以期为中药共线生产提供参考。

Multi-product collinear production is a common situation in drug production.Multi-product collinear pollution and cross pollution control are the key issues in the inspection of drug GMP.The collinear production of traditional Chinese medicine products is common.Due to the complex composition of traditional Chinese medicine,unclear mechanism of action,and difficulty in quantifying trace components,the risk assessment and cleaning verification of collinear production of traditional Chinese medicine products are more complex.This paper summarizes the problems existing in the collinear production and cleaning validation of traditional Chinese medicine,discusses the main considerations of the collinear production and cleaning validation of traditional Chinese medicine,and evaluate the cleaning risk assessment of the collinear production of traditional Chinese medicine,hoping to provide a reference for the collinear production of traditional Chinese medicine.