多品種共線是藥品生產(chǎn)普遍存在的情況，多產(chǎn)品共線的污染、交叉污染控制是藥品生產(chǎn)質(zhì)量管理規(guī)范檢查中重點(diǎn)關(guān)注內(nèi)容。中藥品種間共線生產(chǎn)較普遍，且由于中藥成分復(fù)雜、作用機(jī)制不明確、微量成分定量困難等原因，使中藥品種共線生產(chǎn)的風(fēng)險(xiǎn)評(píng)估和清潔驗(yàn)證的考量點(diǎn)更復(fù)雜。歸納了中藥共線生產(chǎn)和清潔驗(yàn)證存在的問題，探討中藥共線生產(chǎn)和清潔驗(yàn)證的主要考量點(diǎn)，并進(jìn)行了中藥共線生產(chǎn)清潔風(fēng)險(xiǎn)評(píng)估，以期為中藥共線生產(chǎn)提供參考。

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.

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