原料药生产，储罐的物料每次使用还剩点，来新的物料再次注入，是不是混批

beiwei5du · 发表于 2017-8-4 17:06:13

safsaf 发表于 2017-7-1 22:01
进罐后为啥重新请验，合格后方可使用？罐里剩余的物料是已经检测合格的，来新的物料进罐前也是检测合格的 ...

混合后是需要进行检测的

beiwei5du · 发表于 2017-8-4 17:06:25

hongwei2000 发表于 2016-11-15 13:41
槽车是你自己的？
如果不是你自己的
运输公司会等你检验结果？

这种情况下，一般风险可控的情况下，实际操作仅仅可以做鉴别的项目+厂家COAD单就可以呢。仅供参考！
201. One comment on 211.80(a) raised several issues relative to the handling of bulk components being held in storage tanks or silos, including the commingling of a new shipment with the remainder from previous shipments and how such lots should be identified. Combining a new bulk shipment of a component in a bulk storage tank with the remainder of a previously received, tested, and approved component lot causes the compositing of the material. The result is that the previously approved material becomes an integral part of an unapproved new lot and cannot be used until such lot is approved for use. However, a manufacturer may choose not to commingle approved lots with unapproved lots of components in bulk storage. In some instances a manufacturer may be able to test components appropriately before introduction to bulk storage as, for example, when a shipment of components is received with a valid certificate of analysis and where identification testing may be sufficient.

选自https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM095852.txt

赤脚天使 · 发表于 2017-9-28 10:53:07

每天学习新知识

rodedan · 发表于 2019-9-16 19:28:47

beiwei5du 发表于 2017-8-4 17:06
这种情况下，一般风险可控的情况下，实际操作仅仅可以做鉴别的项目+厂家COAD单就可以呢。仅供参考！
2 ...

你好，这个还能找到原文吗？因为里面的链接已经无法打开了。

heiying3210 · 发表于 2022-4-5 15:45:04

zysx01234 发表于 2016-12-16 15:05
不是这么说的，质量负责人（质量受权人）转授权QC经理就可以了，签发一张授权书。

QP没必要所有的放行都抓在手里

zrgjb · 发表于 2022-6-14 14:29:12

谢谢楼主分享

岚中漫步 · 发表于 2022-11-15 09:22:30

谢谢楼主分享

[物料管理] 原料药生产，储罐的物料每次使用还剩点，来新的物料再次注入，是不是混批