疫苗是特殊的藥品。疫苗產(chǎn)品變更管理作為確保質(zhì)量管理有效執(zhí)行的基本要素，其提升方式有助于應(yīng)用到整個(gè)質(zhì)量體系。對(duì)疫苗產(chǎn)品國(guó)內(nèi)變更管理基本要求、世界衛(wèi)生組織（WHO）預(yù)認(rèn)證對(duì)變更控制的總體要求進(jìn)行分析，并結(jié)合企業(yè)通過WHO預(yù)認(rèn)證的變更提升實(shí)例，探討疫苗產(chǎn)品企業(yè)如何系統(tǒng)性提升變更管理業(yè)務(wù)能力，對(duì)接國(guó)際標(biāo)準(zhǔn)。

Vaccines are special drugs, and vaccine product change management is a fundamental element to ensure effective implementation of quality management. Its improvement can be applied to the entire quality system. This article analyzes the basic requirements for domestic vaccine product change management, as well as the overall requirements for change control by the World Health Organization (WHO) prequalification. It analyzes examples of companies' efforts to improve their change management capabilities through WHO prequalification, and explores how vaccine product companies can systematically enhance their change management capabilities and alignment with international standards.

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