batch与lot的不同点的介绍

一沙一叶

这几天翻译东西，看到资料里面一会batch，一会lot，
总体来说
类似于批次与亚批次
我找了一下原版英文介绍
Batch (or Lot)
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
Batch Number (or Lot Number)
A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.

+以上引自Q7a

Batch(lot de fabrication) - A quantity of drug in dosage form, a raw material, or a packaging material, homogeneous within specified limits, produced according to a single production order and as attested by the
signatories to the order. In the case of continuous manufacture, a batch corresponds to a defined fraction of
the production, that is characterized by its intended homogeneity. It may sometimes be necessary to divide a
batch into a number of sub-batches, which are later brought together to form a final homogeneous batch.

Batch Number(numéro de lot de fabrication) - A distinctive combination of numbers and/or letters that
specifically identifies a batch. The batch number appears on the batch records, certificates of analysis, etc.

Lot(lot) - A quantity of any drug in dosage form, a raw material, or a packaging material, homogeneous within specified limits, constituting all or part of a single batch and identified by a distinctive lot number that appears on the label of the finished product.

Lot Number(numéro de lot) - “Any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution.”

开山大斧

高手，要是有翻译就更好了，哈哈

小兵

谢谢分享

道路漫长黑暗

谢谢分享，这个学习了

yuansoul

稍有差异的观点：

batch，原意大烤炉。lot，原意一车。所以，lot不完全是亚批。

davidcone

以下英文源自FDA 21CFR 210

Batch means a specific quantity of adrug or other material that is intended to have uniform character and quality,within specified limits, and is produced according to a single manufacturingorder during the same cycle of manufacture.

指在规定限度内，按照某一生产指令在同一生产周期内生产出来的，具有同一性质和质量的一定数量的药品或其它物料。

Lot means a batch, or a specificidentified portion of a batch, having uniform character and quality withinspecified limits; or, in the case of a drug product produced by continuousprocess, it is a specific identified amount produced in a unit of time orquantity in a manner that assures its having uniform character and qualitywithin specified limits.

指一批或是一批中特定的均一部分，在指定的范围内具有相同的性质和质量；或者若为由连续的生产过程制造出的药品，“批”指在单位时间或单位数量生产出的特定的、均一的部分，并且确保该部分在指定的范围内具有均一性质与质量。

Lot number,control number, or batch number means any distinctive combination of letters, numbers, or symbols, orany combination of them, from which the complete history of the manufacture,processing, packing, holding, and distribution of a batch or lot of drugproduct or other material can be determined.

指由字母、数字、符号或他们的组合组成，由此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。

Gang-printedlabeling meanslabeling derived from a sheet of material on which more than one item oflabeling is printed.

davidcone

其实现在用起来区别都不大了，很多情况下大家都在混着用。我遇到过一个国外的审计官，他的观点是“One BATCH，Several LOT”。

kington

个人认为就是批和亚批的关系，整体质量相对均一，但由于设备、人员等客观原因，可能会存在一定差异时就按Lot分类。比如说同一批配制的药液，使用不同灭菌柜进行灭菌时；同一批片剂使用不同包装生产线进行包装时。

一沙一叶

davidcone 发表于 2014-12-18 14:13
以下英文源自FDA 21CFR 210

哦，明白了gang printing 的意思

lstony1988

kington 发表于 2014-12-18 14:53
个人认为就是批和亚批的关系，整体质量相对均一，但由于设备、人员等客观原因，可能会存在一定差异时就按Lo ...

同意