摘 要：引入藥品質(zhì)量風(fēng)險管理（ICH Q9）理念，嘗試建立口服固體制劑生產(chǎn)質(zhì)量風(fēng)險評價系統(tǒng)。確定了含量偏離、含量波動等8個風(fēng)險因素，通過對多批次藥品風(fēng)險因素的考察來計算各企業(yè)藥品生產(chǎn)風(fēng)險因子，并進行風(fēng)險優(yōu)先數(shù)的排列。以此反映藥品生產(chǎn)企業(yè)工藝穩(wěn)定性，發(fā)掘藥品生產(chǎn)過程的潛在風(fēng)險，旨在前瞻性地發(fā)現(xiàn)藥品生產(chǎn)環(huán)節(jié)的隱患，最大程度避免藥害事件的發(fā)生。

Abstract: This paper introduces the quality risk management（ICH Q9）concept and tries to establish risk assessment system．Eight risk factors are defined including content deviation and content fluctuation．After the study of risk factors in many batches of drugs，the risk figures of every pharmaceutical factory are calculated，and the risk priority numbers are arranged，which reflect the technical stability of pharmaceutical enterprises．This paper aims to discover predictably the potential risks in manufacturing process so as to minimize the adverse drug events．