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：無菌藥品生產(chǎn)
7.我需要執(zhí)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，對潔凈區(qū)的確認和再確認來說，藥品生產(chǎn)商可以應(yīng)用更新后的ISO標準，參考附錄C（微粒計數(shù)），也可以繼續(xù)執(zhí)行之前的ISO標準。日常監(jiān)測則應(yīng)根據(jù)現(xiàn)有附錄1執(zhí)行。
