fdagmp簡(jiǎn)介ppt課件-資料下載頁(yè)
2025-01-14 03:07本頁(yè)面
【正文】 rely upon the finished device manufacturer to assure that ponents are acceptable for use. Component manufacturers are not routinely scheduled for GMP inspections。 however, FDA encourages them to use the QS regulation as guidance for their quality system. When finished device manufacturers produce ponents specifically for use in medical devices they produce, whether in the same building or another location, such production of ponents is considered part of the device manufacturing operations, and the production should ply with the QS regulation as detailed under Manufacturers of Accessories . 問(wèn)題？ FOXLINK OEM 生產(chǎn)需要 GMP認(rèn)證嗎？ 解答： 1. 因?yàn)槟壳拔覀兊?Abbott產(chǎn)品只是屬於藥材包裝，OEM不直接生產(chǎn)藥材，行業(yè)暫無(wú)藥材包裝方面的要求與規(guī)定，所以我們不需要認(rèn)證 GMP，即使要認(rèn)證也將領(lǐng)不到證書。 GMP視頻培訓(xùn)系列 再見 !
教學(xué)課件相關(guān)推薦
鄂ICP備17016276號(hào)-1