中药饮片生产批记录包括“产品标签的实样”，这如何体现。

luhx810302

每批批记录张贴录有产品相关信息（如：品名、批号、生产日期、规格、标准依据等）的标签！

whzg

合格证与标签不一样，标签是粘贴或打印到包装上有生产日期，有效期，批号以及产品信息等内容

浮光掠影315

多打一张标签的实样

anhuirjs

就是那个贴在包装上的标签

wsg771012

附一张带有标签的包装袋

beiwei5du

我个人觉得大标签应该包括，那么如果标签印制在相应的小盒上，最小容器没有标签，那么这样如何操作呢？？？

beiwei5du

小藥工 发表于 2015-6-19 11:08
**** 作者被禁止或删除 内容自动屏蔽 ****

这个问题好！不知道为什么必须要用实样，搞不清楚。其实完全不需要实样，因为实样追溯完全可以通过相应的留样进行。批记录的有两个主要作用，一是指导，而是记录追溯。该法规主要关注在记录追溯层面了。下面是国外FDA cgmp的要求：

§211.186   Master production and control records.
(a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.

(b) Master production and control records shall include:

(8) A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling;

beiwei5du

456. One comment argued that the label should be required to be  maintained on file and not physically attached to the master production or control record.
     The requirement does not state that the label has to be glued or stapled to the master record, for example, if this is what the respondent means by "physically attached."  Since 1963, the CGMP regulations have required that a specimen or copy of each label be included in the master production and control record.  This requirement is needed in order to make the master production and control record complete with respect to all aspects of processing, and should not be changed.
     457. Several comments regarding 211.186(b)(8) and 211.188(b)(8) said lithographed bottles, cans, and ampules cannot be kept on file.
     The Commissioner notes that the final regulations provide that a "specimen or copy" be included in the master and batch production or control record.  A photograph, photocopy, or other accurate reproduction will fulfill the intent of these sections.

CC_UlDTt

附标签实样的原因是什么呢？

薏米田螺

就是包装的标签。附一个在批生产记录中！

龙游天下

结合自己的包装形式，标签和合格证有的企业是合二为一！但必须要附上！

小金库

非常感谢蒲友分享