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[其他] 无菌冻干粉针制剂空调净化系统再确认

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樓主

发表于 2020-9-8 15:34:40 | 只看該作者回帖奖励

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各位，背景：本公司无菌冻干粉针制剂车间空调净化系统停产约5个月，停产过程空调处于停机状态，现在要进行第二次的再确认。請问性能再确认中静态条件下需要做微生物（浮游菌、沉降菌、表面微生物）的项目吗？

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沙發

发表于 2020-9-8 15:43:44 | 只看該作者

全部做，撿漏，風速、風量、粒子、沈降菌、浮遊菌、表面微生物、壓差等等，

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那微生物項目GMP附錄裏不是只有動態的標准嗎？靜態以什麽標准來做呢詳情回複发表于 2020-9-8 16:07

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板凳

发表于 2020-9-8 15:50:31 | 只看該作者

全項都得做

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那微生物項目GMP附錄裏不是只有動態的標准嗎？靜態以什麽標准來做呢？其它項都做了。詳情回複发表于 2020-9-8 16:08

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地板

樓主| 发表于 2020-9-8 16:07:25 | 只看該作者

徐占鳌发表于 2020-9-8 15:43
全部做，撿漏，風速、風量、粒子、沈降菌、浮遊菌、表面微生物、壓差等等，

那微生物項目GMP附錄裏不是只有動態的標准嗎？靜態以什麽標准來做呢

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5^#

樓主| 发表于 2020-9-8 16:08:03 | 只看該作者

wgx1979 发表于 2020-9-8 15:50
全項都得做

那微生物項目GMP附錄裏不是只有動態的標准嗎？靜態以什麽標准來做呢？其它项都做了。

點評

國內企業很多都自行制定了靜態標准，例如把上一級的動態作爲下一級的靜態。你也可以把動態標准直接引用爲靜態標准。最靜態微生物確認以後會成爲強制要求，這一點從歐盟的最新的GMP征求意見稿可以看出。詳情回複发表于 2020-9-8 17:04

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6^#

发表于 2020-9-8 17:04:43 | 只看該作者

熊先生01 发表于 2020-9-8 16:08
那微生物項目GMP附錄裏不是只有動態的標准嗎？靜態以什麽標准來做呢？其它项都做了。

國內企業很多都自行制定了靜態標准，例如把上一級的動態作爲下一級的靜態。你也可以把動態標准直接引用爲靜態標准。對于靜態微生物確認以後會成爲強制要求，這一點從歐盟的最新的GMP征求意見稿可以看出。

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受教了，謝謝。詳情回複发表于 2020-9-8 18:23

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7^#

樓主| 发表于 2020-9-8 18:23:28 | 只看該作者

lszeric 发表于 2020-9-8 17:04
国内企业很多都自行制定了静态标准，例如把上一级的动态作为下一级的静态。你也可以把动态标准直接引用为 ...

受教了，謝謝。

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8^#

发表于 2020-9-9 08:28:12 | 只看該作者

全項都要做，都快半年了培養基模擬灌裝也得重做了吧？

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9^#

发表于 2023-4-22 10:41:36 | 只看該作者

謝謝蒲友分享。

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