仓储区内的原辅料是否每件都要贴质量状态标识？

oyny

欢欢乐乐 发表于 2016-3-2 08:15
公司要求在货位卡上，附有检验报告书，有合格标志。没要求每件贴……

我们跟你们差不多

914908950

以前都贴后来实在太多了，一个月几千包，就没贴了，个人没必要贴，合格代表每包合格，一包不合格，整批不合格。

层云

如果每件都贴的话，那纸箱没有外包装，如何标识每件（确切说每捆）是合格的？

sarah168

田云 发表于 2016-3-9 20:42
如果每件都贴的话，那纸箱没有外包装，如何标识每件（确切说每捆）是合格的？

可以贴在捆纸箱的带子上。

sarah168

oyny 发表于 2016-3-2 10:58
我们跟你们差不多

每件贴，会出现在送料途中合格证掉的情况，实在很头疼。

你们这样也可以吗？欧盟、FDA检查没有问题？

laogai

应该是没个最小包装都要贴。

beiwei5du

以下是美国CGMP以及相关的preamble,仅供参考！§211.80   General requirements.

(d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).

207. Numerous comments on 211.80(d) objected to the proposed requirement to identify each container in a lot being received since many items, such as containers, closures, and excipients are palletized.  This requirement, as proposed, would mandate that each pallet load be broken down so that each unit on the pallet could be identified, then repalletized, thereby increasing the potential for damage and mixups.  This procedure is alleged to have an unnecessary inflationary impact.     The Commissioner recognizes that there are situations where it would be inappropriate to identify each container of component, drug product container, or closure such as mentioned in the proposed regulation.  He agrees that some provision should be made for these situations.  He is therefore amending this paragraph by adding the words "or grouping of containers."  Any individual unit separated from a grouping must be identified with the appropriate information required by this paragraph.（但是当grouping的原辅料或包装材料拆开使用时，这些拆离的unit就必须按照规定进行标示了（包括物料标识和状态标识））

zrgjb

学习学习！！