國(guó)家藥品監(jiān)督管理局啟動(dòng)了藥品檢查合作計(jì)劃(PIC/S)預(yù)加入申請(qǐng),將有助于完善我國(guó)藥品GMP標(biāo)準(zhǔn)?！禤IC/S GMP缺陷分級(jí)指南》是直接影響藥品GMP檢查結(jié)論的關(guān)鍵性文件,其中許多細(xì)節(jié)要求值得我國(guó)藥品檢查機(jī)構(gòu)和檢查員關(guān)注。基于對(duì)《PIC/S GMP缺陷分級(jí)指南》的分析,結(jié)合國(guó)內(nèi)外GMP缺陷分級(jí)標(biāo)準(zhǔn)規(guī)定和具體實(shí)踐,分析了藥品GMP缺陷分級(jí)決策流程和風(fēng)險(xiǎn)評(píng)估,并進(jìn)行了藥品GMP缺陷分級(jí)示例和案例分析,以促進(jìn)我國(guó)藥品GMP檢查進(jìn)一步與國(guó)際接軌。

NMPA has officially launched the PIC/S organization pre-application, which will help improve China's drug GMP standards.“PIC/S Guidance on Classification of GMP Deficiencies” is a critical guidance that directly affect the conclusion of GMP inspection,and many detailed requirements in the guidance are worthy for attention by medicine inspection institutions and inspectors. Based on the study of “PIC/S Guidance on Classification of GMP Deficiencies”, analyzing domestic and foreign GMP deficiencies classification standards and practices, this article analyzes the decision-making process and risk assessment of drug classification of GMP deficiencies, and provides examples and case analysis to promote China's drug GMP inspection to further align with international standards.

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