7.3.2 Start-up checks 生产之前的检查

Before starting any packaging operation, it should be ensured that:在开始包装前要确保：

a)the area has been cleared of materials to avoid mixing with materials from previous operations; 上一个操作完毕后要对所在区域进行清线以避免混用。

b)all documentation relevant to the packaging operations, is available;有关包装的相关文件是可获得

c)all packaging materials are available;所有包装材料到位

d)suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;使用了适合的设备，对要

用到的设备进行清洗必要时进行了消毒

e) any coding to permit identification of the product is defined.要确定任何产品的识别码无误。

7.3.3 Assignment of batch number 批号的确定

7.3.3.1A batch number should be assigned to each unit of finished product.每组成品的批号要被确定

7.3.3.2This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if not, it should

be easy to relate to that number. 每个产品要有批号，虽然并不需要和散装产品上的批号完全相同，但应当与散装产品的批号相关联。

7.3.4 Packaging line identification 包装生产线识别

At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying code of the fi

nished product and the batch number.在任何时候，可通过包装生产线的名称或识别码，成品名称、识别码或批号。

7.3.5 Checks of on-line control equipment 在线监控设备的检查

If used, on-line control equipment should be regularly checked according to a defined programme.如果使用这样的设备，

应根据相关文件对这些设备进行定期检查

7.3.6 In-process control 过程控制

7.3.6.1In-process controls and their acceptance criteria should be defined.制定过程控制的可接受准则

7.3.6.2In-process controls should be performed according to a defined programme.

过程控制要按确定的程序进行

7.3.6.3 Any result that is outside the acceptance criteria should be reported and appropriately investigated.

报告超出准则的结果并分析

7.3.7 Re-stocking of packaging materials 包材再储存

If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock, their containers

should be closed and properly identified.包装剩下的包材返还到仓库时要被标识，并且盛装的容器要被封口和标识。