【CFDA审核查验中心】来料验货问题

北重楼

咨询内容：老师你好！请问原料、辅料来料时都必须开箱每瓶检查吗？当来料几百箱时，可操作性不强。外箱上的除物料信息外的标签如物流标签都要撕毁吗？
回复：这个问题首先应建立一个风险分析的机制，并在供应商审计的基础上进行。如无菌原料药的风险高，应每件包装进行检查，但考虑到污染的风险较高，不可轻易打开内包装。如供应商审计时该企业无外观相似的产品，可不必每件都打开取样鉴别；如有单发的用于检测的小包装，可对其进行鉴别检查；如原辅料系供应中间商提供，尤其是曾被分包装过的，则属于必须每件检查的范围；企业如有近红外扫描设备，也可以不开箱检查，直接每件扫描鉴别即可。这种鉴别不可混样后操作。物流标签如已覆盖物料信息，或严重影响外观，可撕毁。


http://www.cfdi.org.cn/cfdi/index?module=A004&part=localfrm&tcode=STA026&id=240827

小美2005

学习了

紫幻剑雨888

学习了。谢谢分享

xqliu

这样的回复比较到位

beiwei5du

我觉得官方是将“来料验收”和“来料取样检查”的混淆了吧。

beiwei5du

这个可以作个参考§211.82   Receipt and storage of untested components, drug product containers, and closures.

(a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

213. A number of comments on 211.82(a) said individual containers of components, containers, and closures need not be visually examined before acceptance as long as they are checked before use.  The rationale for the comments is that a visual check of each container is impractical and unrealistic for large shipments of bagged materials that are palletized as a unit and/or shrink-wrapped.  The respondents suggested that tearing apart materials packaged in that manner would be costly and could be better done before use rather than in a receiving area.     It was the Commissioner's intent in this paragraph to provide for a simple check at the time of receipt to detect obvious problems such as the wrong article, damaged containers, or visible contamination which would preclude any further handling of the materials.  He recognizes, however, that individual container examination of large lots of bagged or boxed materials is impractical when they are received.  Therefore, this requirement is revised to provide for examination of each container or grouping of containers.     214. A number of comments expressed concern over the possibility of contamination if containers of components and other materials are opened for examination in the receiving areas of factories.  To avoid cross-contamination it was suggested that examinations be limited to the exterior of the containers or to shipping containers.     The Commissioner notes that this paragraph does not specify that seals must be broken for purposes of examination.  It is the intent of this paragraph that a visual examination be performed. In most cases it would be adequate to limit the examination to shipping containers.  If the firm feels an inspection should be made in depth, proper precautions must be taken to prevent cross-contamination.