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蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英論壇 › 化學藥品 › 化學原料藥 › 國內GMP證書編號

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[原料藥] 國內GMP證書編號

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樓主

发表于 2015-10-27 11:27:51 | 只看該作者回帖獎勵

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国内首次申請时，只有一个产品获得一张GMP證書，當再次複審時，增加了一個新的産品，這增加了一個産品的GMP證書編號是原來的證書編號還是會給一個新的編號？

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沙發

发表于 2015-10-27 11:32:27 | 只看該作者

回帖獎勵 +1 金幣

路過學習學習

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板凳

发表于 2015-10-27 11:34:07 | 只看該作者

路過學習學習

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地板

发表于 2015-10-27 12:51:11 | 只看該作者

原料藥是這樣制劑是按劑型不同劑型的可能需要重新認證合並，具體需要咨詢當地局

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5^#

发表于 2015-10-27 13:50:38 | 只看該作者

國內認證是按生産線認證的，又不是按産品

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6^#

樓主| 发表于 2015-10-27 14:55:16 | 只看該作者

ziyiwoaini 发表于 2015-10-27 12:51
原料藥是這樣制劑是按劑型不同劑型的可能需要重新認證合並，具體需要咨詢當地局

原料药是直接加上去，證書编号不变吗？

點評

原料药是每一个品种一个GMP證書，当然目前也允许一起认证，證書是一张。分开认证，每次认证一张，制剂是每次每条生产认证一张詳情回複发表于 2015-10-27 16:25

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7^#

樓主| 发表于 2015-10-27 14:55:42 | 只看該作者

tanya0906 发表于 2015-10-27 13:50
國內認證是按生産線認證的，又不是按産品

你說的是制劑吧？我們是API

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8^#

樓主| 发表于 2015-10-27 15:01:04 | 只看該作者

ziyiwoaini 发表于 2015-10-27 12:51
原料藥是這樣制劑是按劑型不同劑型的可能需要重新認證合並，具體需要咨詢當地局

还想问下，欧洲的EU GMP證書有的是写的产品，有的写的是人用药品，这个也是这样嘛？列产品的是API，列huamn medical products是指的生产线？

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9^#

发表于 2015-10-27 16:25:30 | 只看該作者

凱普徐发表于 2015-10-27 14:55
原料药是直接加上去，證書编号不变吗？

原料药是每一个品种一个GMP證書，当然目前也允许一起认证，證書是一张。分开认证，每次认证一张，制剂是每次每条生产认证一张

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