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[质量保证QA] 开箱贴签检查???

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发表于 2017-8-6 15:32:03 | 显示全部楼层 |阅读模式
制剂生产完后,是否一定要开箱取样进行贴签检查呢????如果是三级或以上包装,那么是否还会深入到下一层进行开盒贴签检查吗???§211.134   Drug product inspection.

(a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.

(b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.

(c) Results of these examinations shall be recorded in the batch production or control records.

我知道答案 本帖寻求最佳答案回答被采纳后将获得系统奖励2 金币 , 目前已有14人回答
 楼主| 发表于 2017-8-6 15:37:56 | 显示全部楼层
350. A comment argued that the wording of 211.134(b) implies that the "representative sample" should be taken from sealed and palletized shipping cases.    If shipping containers are labeled to contain a particular drug product, then it is the Commissioner's intention that individual shipping containers be examined to assure that the correct drug product is in the appropriate containers.  A lot or batch does not necessarily have to be sampled after it has been palletized because, generally speaking, palletizing is not considered as part of the finishing operation referred to in 211.134(b).

如果贴签是执行的切割标签,并进行的设备和人工的100%的检查,那么是否还需要在包装后拆箱取样进行目视贴签检查吗???

(g) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operations shall include one of the following special control procedures:

(1) Dedication of labeling and packaging lines to each different strength of each different drug product;

(2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or

(3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person.

(4) Use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment.

发表于 2017-8-6 15:55:07 | 显示全部楼层
发表于 2017-8-6 16:13:48 | 显示全部楼层
发表于 2017-8-7 09:02:16 | 显示全部楼层
表示看不懂。。。。
发表于 2017-8-9 11:43:42 | 显示全部楼层
没有说封签后再开包检查,条款原文讲的很清楚,是包装过程中或者是包装完成后要执行检查
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 楼主| 发表于 2017-8-9 11:49:25 | 显示全部楼层
julia朱玉姣 发表于 2017-8-9 11:43
没有说封签后再开包检查,条款原文讲的很清楚,是包装过程中或者是包装完成后要执行检查

completion of finishing operations 包装完成后如何理解??是外包完成后???“If shipping containers are labeled to contain a particular drug product, then it is the Commissioner's intention that individual shipping containers be examined to assure that the correct drug product is in the appropriate containers”如何理解呢??
发表于 2017-8-9 11:51:53 | 显示全部楼层
发表于 2017-8-9 11:53:08 | 显示全部楼层
这段话不是法规,貌似有人写的评议讨论文章
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 楼主| 发表于 2017-8-9 11:54:39 | 显示全部楼层
julia朱玉姣 发表于 2017-8-9 11:53
这段话不是法规,貌似有人写的评议讨论文章


这个是FDA针对于GMP修订的回复呢。反正是哪个时候的官方回复
https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM095852.txt
发表于 2017-8-9 12:08:33 | 显示全部楼层
这个说不上是回复,只是解释法案修订时收到的一些comments,诠释立法者意图,不能作为法规引用,其地位低于指南。具体说这个350的意思,立法本意并不需要对运输打包进行开包检查至最小包装,只需要确认运输货包内确实是该药品即可。打托过程并不作为是法规211.134 b里finishing operation的一部分。因此讨论你说的这几个法规条款时不应牵扯发运打包操作。或者说,你如果想要讨论发运打包操作,就不应该引用这两个条款。
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发表于 2017-8-9 12:15:15 | 显示全部楼层
至于说finishing operation 具体包括哪些操作,这个没法一一列举,因为各家会不一样。一般认为是到报批文件写明的最大包装为止,不包括为了运输过程保护而额外添加的包装,如托盘,支撑性加固,防雨罩。至于是不是非要全部包装操作完成后再拆包取样至最小包装,法规并没有强制要求,是各公司要论证的,可以是过程检查,特别是目前电子100% 检查,很容易实现的
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 楼主| 发表于 2017-8-9 12:24:15 | 显示全部楼层
julia朱玉姣 发表于 2017-8-9 12:15
至于说finishing operation 具体包括哪些操作,这个没法一一列举,因为各家会不一样。一般认为是到报批文件 ...

主要使其回复的在completion of finishing operations后必须检查,而且这个检查结果需要在批记录中进行体现,就不太清楚其是否在外包装完了后臭氧检测呢??还有这个§211.134法规并未考虑到§211.122   Materials examination and usage criteria.中针对于cut labeling中如果针对于每次贴签都进行100%人工检查的情况,这种情况下就没有必要再包装完成后进行correct labeling的检查了啊!
发表于 2018-9-14 23:57:30 | 显示全部楼层

看都看不懂
发表于 2018-9-20 15:30:12 | 显示全部楼层
山东烟台qa方向的岗位,两年qa经验  待遇10w-30w
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