fdagmp簡(jiǎn)介ppt課件-wenkub.com
2025-01-11 03:07 本頁(yè)面
【正文】 廠房輿設(shè)施要求 Types of Establishments Subject to the GMP適用 GMP企業(yè)類型 聯(lián)邦規(guī)章法典 21篇 82..30(a)節(jié) ，否則就要符合 GMP要求 ，雖然單獨(dú)包裝，輿主體 分離，這類也必須符合 GMP (custom)或?qū)Ｓ?(customized)的名義的器械也必須遵守規(guī)范 但 FDA不會(huì)做例行檢查 、再標(biāo)示者和技術(shù)說(shuō)明制定者 Types of Establishments Exempt from GMP豁免 GMP企業(yè)類型 Component Manufacturers A ponent is defined by 21 CFR (c) as any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. Component manufacturers are excluded from the QS regulation by 21 CFR (a)(1). Current FDA policy is to rely upon the finished device manufacturer to assure that ponents are acceptable for use. Component manufacturers are not routinely scheduled for GMP insp
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