藥學(xué)研制現(xiàn)場(chǎng)核查主要是對(duì)藥學(xué)研制情況開(kāi)展的核查工作。近年來(lái)藥品注冊(cè)研制現(xiàn)場(chǎng)核查發(fā)現(xiàn)，藥學(xué)研制階段存在諸多問(wèn)題，如真實(shí)性、一致性、數(shù)據(jù)可靠性、技術(shù)轉(zhuǎn)移問(wèn)題，因此建議藥品研制單位進(jìn)行規(guī)范性建設(shè)，建立與研制行為相匹配的質(zhì)量管理體系，加強(qiáng)數(shù)據(jù)可靠性管理，構(gòu)建完善的技術(shù)轉(zhuǎn)移過(guò)程。分析了藥學(xué)研制現(xiàn)場(chǎng)核查的問(wèn)題，提出建議，希望為藥學(xué)研制工作規(guī)范化提供參考。

The on-site verification of pharmaceutical research mainly verifies the status of pharmaceutical research work. In recent years, on-site inspections of drug registration and development have found that there are many problems with authenticity, consistency, data reliability, and technology transfer in the pharmaceutical development stage. Therefore, it is recommended that drug development enterprises carry out standardized construction, establish a quality management system that matches their research and development behavior, strengthen data reliability management, and build a sound technology transfer process. This article analyzes the problems of on-site verification in pharmaceutical development and proposes suggestions, hoping to provide reference for the standardization of pharmaceutical development work.

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