近年來，在國內(nèi)外生物制品生產(chǎn)現(xiàn)場檢查中發(fā)現(xiàn)生產(chǎn)設(shè)備方面的問題較為突出。對生物制品生產(chǎn)設(shè)備的檢查是基于藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）標(biāo)準(zhǔn)規(guī)定開展的，因此對無菌生物制品原液生產(chǎn)設(shè)備、制劑生產(chǎn)設(shè)備和一次性使用系統(tǒng)的檢查要點(diǎn)進(jìn)行總結(jié)和分析，并列舉了國內(nèi)外生物制品檢查典型問題，探討在各類檢查和自查中如何提高對生物制品生產(chǎn)設(shè)備的檢查實(shí)效，同時(shí)也為生物制品行業(yè)進(jìn)一步加強(qiáng)生產(chǎn)設(shè)備的管理提供參考。

In recent years, prominent issues have been found in the production equipment during on-site inspections of biological products at home and abroad. The inspection of biological product production equipment is based on the provisions of Good Manufacturing Practice (GMP) standards for drug production. This article summarizes and analyzes the inspection points of sterile biological bulk and finished product production equipment, formulation production equipment, and single-use system, and lists typical problems in biological product inspection at home and abroad. It explores ways to improve the inspection effectiveness of biological product production equipment in various inspections and self-inspections, and also provides reference for further strengthening the management of production equipment in the biological product manufacturers.

R951