在藥品生產(chǎn)企業(yè)的質(zhì)量管理中，產(chǎn)品質(zhì)量回顧涉及質(zhì)量控制、質(zhì)量保證和質(zhì)量改進(jìn)。部分藥品生產(chǎn)企業(yè)未能有效開展產(chǎn)品質(zhì)量回顧，導(dǎo)致在藥品異常質(zhì)量趨勢識別、藥品質(zhì)量的持續(xù)改進(jìn)和質(zhì)量管理水平的不斷提升方面存在不足。通過對國內(nèi)外關(guān)于藥品質(zhì)量回顧的法規(guī)進(jìn)行梳理，明確了有效開展藥品質(zhì)量回顧的要點(diǎn)：程序文件規(guī)定、回顧頻次、回顧內(nèi)容、統(tǒng)計(jì)分析方法、回顧問題的識別與分析、回顧結(jié)論、質(zhì)量回顧報(bào)告的審核與管理，并對產(chǎn)品質(zhì)量回顧檢查中常見問題進(jìn)行了分析。

In the quality management of pharmaceutical manufacturing companies, product quality review involves quality control, quality assurance, and quality improvement. Some drug manufacturers fail to carry out product quality review effectively, which leads to deficiencies in the identification of abnormal drug quality trends, continuous improvement of drug quality, and continuous improvement of quality management level. By sorting out the domestic and foreign laws and regulations on drug quality review, this paper clarifies the main points of effectively carrying out drug quality review:procedure document regulations, review frequency, review content, statistical analysis methods, identification and analysis of review problems, review conclusions, and quality review and management of reports, and analyze common problems in product quality review inspections.

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