350. A comment argued that the wording of 211.134(b) implies that the "representative sample" should be taken from sealed and palletized shipping cases. If shipping containers are labeled to contain a particular drug product, then it is the Commissioner's intention that individual shipping containers be examined to assure that the correct drug product is in the appropriate containers. A lot or batch does not necessarily have to be sampled after it has been palletized because, generally speaking, palletizing is not considered as part of the finishing operation referred to in 211.134(b).
如果贴签是执行的切割标签，并进行的设备和人工的100%的检查，那么是否还需要在包装后拆箱取样进行目视贴签检查吗？？？
(g) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operations shall include one of the following special control procedures: (1) Dedication of labeling and packaging lines to each different strength of each different drug product; (2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or (3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person. (4) Use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment. | 
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