FDA官方问答（二）中英文对照

Q：Can containers,closures, and packaging materials be sampled for receipt examination in thewarehouse?

问题：容器、瓶盖和包装材料可以在仓库进行接收检查么？

A：Yes.Generally,webelieve that sampling in a typical drug manufacturing facility warehouse wouldnot represent a risk to the container/closure or affect the integrity of thesample results.But whether the act of collecting a sample in the warehouseviolates the CGMPs requirement that containers "be opened, sampled,andsealed in a manner designed to prevent contamination of their contents..."will depend on the purported quality characteristics of the material undersample and the warehouse environment. For container/closures purporting to besterile or depyrogenated, sampling should be under conditionsequivalent to the purported quality of the material: a warehouse environmentwould not suffice (see 211.94 and 211.113(b)).  This is to preserve thefitness for use of the remaining container/closures as well as ensure sampleintegrity, if they are to be examined for microbial contamination.  At aminimum, any sampling should be performed in a manner to limit exposure to theenvironment during and after the time samples are removed (i.e., wiping outsidesurfaces, limiting time that the original package is open, and properlyresealing original package). Well-written and followed procedures are thecritical elements.

回答：可以。一般说来，我们相信在一个典型的药厂的仓库取样不会对容器/瓶盖产生风险或者影响取样结果的完整性。但是，仓库的取样行为是否会违反CGMPs的要求容器“被打开、取样、密封的方式应防止污染其内容物…”，这要取决于取样物料的性质和仓库环境。对于声称是无菌或除热源的容器或盖子，取样条件应物料的质量性质：仓库环境是不够的。这是为了保证剩余容器/盖子的适用性，以及样品的完整性，如果它们将会被进行微生物检查。最低程度，任何取样方式都要限制样品移取过程和取走之后在环境中的暴露（即擦拭外表面，限制初始包装打开时间，适当的重新封口）。写好并执行程序时关键因素。

Note that the CGMPs at211.84 permit a manufacturer to release for use a shipment ofcontainers/closures based on the supplier's certificate of analysis and a visualidentification of the containers/closures.  Once a supplier's reliabilityhas been established by validation of their test results, a manufacturer couldperform the visual examination entirely in the warehouse.

注意CGMPs211.84允许生产商依据供应商的COA和对容器/盖子的目视鉴别来放行容器/盖子用于生产使用。一旦通过验证他们的检验结果确立了对供应商的信任，生产商可以在仓库仅进行目视检查。

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