今年3月份更新的ECA注射剂灯检指南中关于此问题的相关规定如下:
Visual Inspection of Medicinal Products for Parenterals Use
注射用药品的目检
ECA | 2024-03
https://lib.shilinx.com:443/u/mz569t
4.2 Routine Operation
During routine operation the overall functional performance of the automated system should be demonstrated to be within the acceptable range of the normal operating conditions and validated state. This is achieved by using a test set containing representations of the range of defects that has been used in the qualification, which should be applied before and after the inspection of a batch. An abridged or reduced function set may also be used. In the event of a risk, such as a malfunction or machine drifts (misalignments of visual components, camera defects, etc.) of the inspection system, the described functional test can also be useful within a batch
在常规操作期间,应证明自动化系统的整体功能性能在正常运行条件和验证状态的可接受范围内。应使用包含确认集的代表性缺陷品的测试集,并应在批目检之前和之后都进行测试。还可以使用简化或缩减的功能集。如果出现风险,例如目检系统发生故障或机器漂变(视觉组件错位、相机缺陷等),在批目检期间也进行该功能测试。
总结下:批目检前后需要进行确认,另外,如果出现异常情况,应批目检期间进行确认。
这个挑战测试可以理解为功能性测试,用特殊的功能性测试样品确认商业化过程中设备性能(功能性)稳定(基于设备PQ/PPQ通过基础上),定期一般可以认为在生产前和生产后进行确认,过程中一般不建议,因为功能性测试样品与商业化产品混淆风险比较大,可以增加过程中人工抽样目检,辅助进行确认,当连续生产时(仅限于次日仍为相同产品全自动智能灯检的情况),第一批生产后测试和第二批生产前测试可合并。关于功能性测试样品,ECA有相关描述https://lib.shilinx.com/wiki/index.php?title=ECA_Which_Test_Sets_are_used_in_the_100%25_Visual_Inspection_20230425
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