Q7：

8.12 Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended  intermediate or API.

关键的称量、计量或分装操作应当有复核或有类似的控制手段。使用前，生产人员应当核实所用物料正确无误。

8.13 Other critical activities should be witnessed or subjected to an equivalent control.

其它关键操作也应当有复核或有类似的控制手段。

APIC - How to do ?

8.12 Companies should define the critical weighing, measuring or subdividing operations which should be witnessed or subject to an equivalent control to the minimum number General non-critical weighing or measuring of materials does NOT require witnessing.

企业应明确需由第二人复核或实施等效控制措施的关键称量、计量及分装操作，并将其数量控制在最低限度。对于常规的非关键物料称量或计量操作，则无需进行复核。

As it was seen in the step 2 ICH Q7 document it was intended that such weighing operations should be “supervised”, which would not have required the physical presence of a second person. However, the word “supervised” suggests that someone more senior in the organisation should carry out this task. To avoid this interpretation the word “witnessed” was chosen to indicate that anyone could carry out this check.

正如在ICH Q7中所规定，原本计划此类称重操作应由他人“监督”，但这并不要求必须有第二个人在场。然而，“监督”一词容易让人误解为需由组织中更高级别的人员来执行此任务，为避免这种误解，改用“见证/复核”一词，以明确表示任何人皆可进行此项检查。

However, it was not intended that this word should be used within the narrow legal sense of being physically present throughout the operation and a subsequent check of a second person would fulfil the requirement.                                                     

然而，使用该词并非意在将其含义局限于狭义的法律层面，即并非要求在整个操作过程中始终在场，而是由第二人在操作完成后进行事后检查即可满足要求。

A typical equivalent control that avoids the need for a second person is a recording system where all weighing or measuring operations are detailed. The critical weights or volumes should be confirmed at the end of the batch production.

一种典型的等效控制方法（可避免第二人在场），是通过记录系统详细记录所有称量或计量操作。关键的重量或体积应在批次生产结束时进行确认。

补充说明：

1、所有需经第二人复核或审核的记录，务必详尽记录（尤其是用于决策的信息），应避免使用含糊不清的表述，以确保复核人或审核人能基于完整信息做出准确判断。

2、根据风险管理原则，针对高关键性数据，除了进行实时记录外，还需由同级人员实施实时复核（即“四眼原则”），并要求质量部门进行后续审核。例如，在向设备投料时，若称量数据未通过电子方式采集且天平未连接打印机，则必须由一人负责记录称量值，另一人同步确认实际加入设备的物料量无误且记录准确。    

The final check by production that the identity and lot numbers of dispensed raw materials comply with the batch instructions may also include a check of the quantities or volumes of critical measurements These checks should be clearly defined in the operating instructions for each batch.                                           

生产部门需对已发放原料的身份和批号是否与批指令相符进行最终核查，亦可涵盖对关键计量指标如量或体积的审核。此类检查应在每批产品操作规程中予以明确规定。

8.13 Companies should decide which operations other than weighing and dispensing could be considered critical and therefore should be witnessed or subject to additional controls. Examples are:                            

公司应确定除称量和分装外还有哪些操作属于关键操作，从而需进行第二人复核或采取额外的控制措施。例如：

• Charging of critical raw materials.关键原料的投料；

• Control of critical temperatures, pressures, times.关键温度、压力、时间的控制；

• Point of crystallisation of API where this is critical to the control of polymorphs.对原料药晶型控制至关重要的结晶点控制；

• Operations that are critical (and thus subject to these controls) should be documented on the Batch Production Records and related documents.

被认定为关键操作（因此需执行相应控制措施）的步骤，应详细记录在批生产记录及相关文件中。