GMP] 法國CARGILL FRANCE公司 EU GMP檢查失敗
法國CARGILL FRANCE公司 EU
GMP檢查失敗
產(chǎn)品為非無菌原料藥，不符合情況如下：
Nature of non-compliance : Overall, 14 observations were made, including 1 critical deficiency and 4 major deficiencies:
總共發(fā)現(xiàn)14個缺陷，包括1個關(guān)鍵項，4個主要項。
[Critical] The management of semi-finished batches and of the mixing operations was deficient and conformity of the final batches to specifications,
notably Ph.Eur. specifications, could not be guaranted.
[關(guān)鍵缺陷] 半成品批次和混合擔任有缺陷，不能保證最終批產(chǎn)品符合質(zhì)量標準，特別是歐洲藥典
[Major 1] The site had been manufacturing an active substance without ANSM authorisation.
[主要缺陷 1] 現(xiàn)場曾未經(jīng)ANSM批準生產(chǎn)一個原料藥
[Major 2] The change control related to the suppression of one filtration step in the active substance manufacturing
process was deficient.
[主要缺陷 2] 原料藥生產(chǎn)工藝中一個壓濾步驟有關(guān)的變更控制有缺陷
[Major 3] The manufacturing of the active substance had not been made using master production instructions and no batch
production records had been established.
[主要缺陷 3] 原料藥生產(chǎn)未使用工藝規(guī)程，沒有建立批生產(chǎn)記錄
[Major 4] No review of batch production records of critical process steps had been done before release of the active
substance for distribution.
[主要缺陷 4] 在原料藥放行銷售前，沒有對關(guān)鍵工藝步驟批生產(chǎn)記錄進行審核
7 observations are related to lack of traceability, risks of contamination induced by the absence of cleanliness in
the production environment, very bad condition of the production equipment and insufficient equipment cleaning procedures.
The inspection’s observations also applyto the manufacture of pharmaceutical excipients and starting materials that are
intended to be used as ingredients in cosmetics and medical devices, which are manufactured under the same conditions as
the active substance.
7個缺陷與可追溯性缺乏、生產(chǎn)環(huán)境沒有缺陷導(dǎo)致污染風(fēng)險、生產(chǎn)設(shè)備條件很差、設(shè)備清潔程序不充分有關(guān)。檢查人員發(fā)現(xiàn)的缺陷也存在于藥用輔料
和用于化妝品和醫(yī)療器械輔料生產(chǎn)的起始物料的生產(chǎn)中，這些物料是在與原料藥一樣的條件下生產(chǎn)的。
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