7.2.3 Assignment of a batch number 确定批号
A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number.
应指定散装产品的批号,虽然并不需要和成品上的批号完全相同,但应当与成品的批号相关联。
7.2.4 Identification of in-process operations 过程操作的确认
7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing.
根据配方,所有的原料都应被计量或称量,投入于干净适合的有适当标识的容器里或者直接投在生产设备当中。
7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products.
在任何时候都需识别主要设备,盛原料和散装产品的容器。
7.2.4.3 Identification of containers of bulk products should indicate:盛散装产品的容器的标识:
a)name or identifying code;名称和识别码
b)batch number;批号
c)storage conditions when such information is critical to assure the quality of the product.当此信息对产品质量重要时标
识储存条件
7.2.5 In-process control 过程控制
7.2.5.1 In-process controls and their acceptance criteria should be defined.
过程控制及其可接受准则应确定
7.2.5.2 In-process controls should be performed according to a defined programme.
过程控制要按确定的程序进行
7.2.5.3 Any result outside the acceptance criteria should be reported and appropriately investigated.
要报告任何超出规定的结果并做分析