退回标签应怎么处理？？？

beiwei5du

§211.125   Labeling issuance.

(a) Strict control shall be exercised over labeling issued for use in drug product labeling operations.

(b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records.

(c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with §211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with §211.122(g)(2). Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers.

(d) All excess labeling bearing lot or control numbers shall be destroyed.

(e) Returned labeling shall be maintained and stored in a manner to prevent mixups and provide proper identification.

(f) Procedures shall be written describing in sufficient detail the control procedures employed for the issuance of labeling; such written procedures shall be followed.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993; 81 FR 81697, Nov. 18, 2016]

请问退回标签需要和原标签区分开，并有相应的标识区分吗？？

ych81585

要看公司制定的SOP怎么制定的

zysx01234

其实我更好奇的是，你们标签怎么发放的，数量如何控制

吖倪吖赛

我也很关心贵公司管制包材是如何发放的？

睿睿妹妹

整件发放，零头每张点

cnosema

原文里没有提到“原标签”哈，只是说有适宜的标识防止弄混。

这个弄混，可以是和其它标签弄混呀。这些退回的标签，和“原标签”就没有区别的嘛。对于打印了批号或者控制号的标签，就没有退回的问题了，就销毁了（（d）里明确说了）。

beiwei5du

zysx01234 发表于 2017-6-29 11:39
其实我更好奇的是，你们标签怎么发放的，数量如何控制

如果多的话，当然是按照厂家发货量估计，准确技术比较浪费资源。

beiwei5du

cnosema 发表于 2017-6-29 21:58
原文里没有提到“原标签”哈，只是说有适宜的标识防止弄混。

这个弄混，可以是和其它标签弄混呀。这些退 ...

是的。但是针对于cut label的退回可能需要一张一张检查，防止混入其他标签吧！