When applying visual inspection to determine cleanliness of equipment, manufacturers should establish the threshold at which the product is readily visible as a residue. This should also take into account the ability to visually inspect the equipment, for example, under the lighting conditions and distances observed in the field.
在进行目视检查确定设备的清洁度时，生产商应建立产品易于目视残留的阈值。这时也可以考虑目视检查设备的能力，例如，现场的照明条件和观察距离。
Visual inspection should include all product contact surfaces where contamination may be held, including those that require dismantling of equipment to gain access for inspection and/or by use of tools (for example mirror, light source, boroscope) to access areas not otherwise visible. Non-product contact surfaces that may retain product that could be dislodged or transferred into future batches should be included in the visual inspection.
目视检查应包括所有可能留有清洁的产品接触表面，包括需要拆卸以进入检查和/或使用工具进行检查的设备（例如，镜子、光源、管道镜）以观察这些目视不可及的区域。目视检查中应包括可能残留产品的非产品接触表面，而残留可能在未来掉落或转移至后续批次中的情况。
Written instructions specifying all areas requiring visual inspection should be in place and records should clearly confirm that all inspections are completed.
应制订书面指令指明需要目视检查的所有区域，记录应清楚确认已完成所有检查。
Operators performing visual inspection require specific training in the process including periodic eye sight testing. Their competency should be proven through a practical assessment.
执行目视检查的操作人员需要进行特定培训，包括定期视力检查。应通过实际评估来证明其资质。