转移方和接收方的生产量和批量大小应进行比较。当批量大小不同时，应评估其影响，计划并采取适当的措施。与待审查设备有关的其他因素可能包括:

• minimum and maximum capacity;

• 最小和最大能力

• material of construction of contactsurfaces;

• 接触表面的构造材料

• critical operating parameters;

• 关键操作参数

• components (e.g. filters, screens, andtemperature/pressure sensors); and

• 组件(例如过滤器、筛和温度/压力传感器);和

• range of intended use.

• 预计使用范围

9.6. The impact of the potential product to be transferred, on existingproducts manufactured on site, should be assessed.

应评估待转移产品对现场生产的现有产品的影响。

10. Qualification and validation

确认与验证

10.1. The extent of qualification and validation to be performedshould be determined on the basis of risk management principles.

应根据风险管理原则确定确认和验证的范围。

10.2. The qualification of premises, utilities and equipmentshould be done in accordance with a qualification master plan and protocols.

厂房、公用设施和设备的确认应按照确认主计划和方案进行。

10.3. Validation, such as process validation, should be done inaccordance with a validation master plan and protocols.

验证，例如工艺验证，应该按照验证主计划和方案进行。

10.4. Where technology is transferred to commercial sites, thequalification of equipment and instruments should be completed prior to theactual technology transfer.