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新的ISO 14644發(fā)布，但EU GMP附錄1更新還未發(fā)布，要按什么標準檢測？EMA在其官網(wǎng)上的問(wèn)答中給出了回答。

EUGMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterilemedicinal products

7. Do Ineed to follow the requirements of the updated ISO 14644 part 1 standard?

Annex1 of the EU GMP guide is currently under revision and will take account of theupdated ISO standard. In the meantime, for qualification or re-qualification ofclean room facilities, medicinal productmanufacturers may apply the updated ISO standard with reference to Annex C(counting of macroparticles), or may continue to follow the previous ISOstandard. Routine monitoring, however, should continue to be carried out inaccordance with the existing Annex 1.

EUGMP指南附錄：補充要求：附錄1：無(wú)菌藥品生產(chǎn)

7.我需要執行更新后的ISO14644第一部分標準要求嗎？

EUGMP指南附錄1目前正在修訂中，其修訂將考慮更新后的ISO標準。同時(shí)，對潔凈區的確認和再確認來(lái)說(shuō)，藥品生產(chǎn)商可以應用更新后的ISO標準，參考附錄C（微粒計數），也可以繼續執行之前的ISO標準。日常監測則應根據現有附錄1執行。

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&mid=WC0b01ac05800296ca