2.4 Performance Qualification (PQ)
2.4.1 Performance qualification should provide documented evidence that a piece of
equipment or system delivers the performance characteristics in conformance with
its predetermined design criteria and specifications.
2.4.2 PQ should follow an authorised protocol and may include, but not be limited to,
the following:
(a) tests using production materials (or qualified substitutes and/or simulated
product) that have been developed from specialist knowledge of the process
and how the equipment or system is intended to deliver its performance
characteristics.
(b) studies utilising production materials (or qualified substitutes and/or simulated
product) to include a condition or set of conditions encompassing upper and
lower operating limits.
这是欧盟GMP附录15中的内容，请问，
PQ中的操作参数上限和下限如何确认？
例如混粉机，加入说上限是100公斤，中限是80公斤，下限是60公斤；那么PQ确认阶段需要进行3个限度，总共9次运行吗？还是只是进行正常批量一个中限的3次运行。
各位战友，这个问题是很难啊，还是很容易啊？
给个意见。
既然是做PQ，当然希望做到极限条件，比如灌封机，肯定要在最快速度和最慢速度时进行运行确认，考察设备的性能是否与说明书一致和运行稳定性情况。
个人认为，可以用替代或模拟产品做上限和下限的设备性能确认（6次），用正常生产产品（中限）进行工艺验证（3次，实际和性能确认合并一起做了）。
就象购买一台设备，是否说明书中的所有功能都需要确认，而所有功能中，平时使用的仅仅是2～3个。如果你有时间的话，当然所有的功能都要做，这样是对于购买设备的负责。
2.4.1 Performance qualification should provide documented evidence that a piece of
equipment or system delivers the performance characteristics in conformance with
its predetermined design criteria and specifications.
2.4.2 PQ should follow an authorised protocol and may include, but not be limited to,
the following:
(a) tests using production materials (or qualified substitutes and/or simulated
product) that have been developed from specialist knowledge of the process
and how the equipment or system is intended to deliver its performance
characteristics.
(b) studies utilising production materials (or qualified substitutes and/or simulated
product) to include a condition or set of conditions encompassing upper and
lower operating limits.
这是欧盟GMP附录15中的内容，请问，
PQ中的操作参数上限和下限如何确认？
例如混粉机，加入说上限是100公斤，中限是80公斤，下限是60公斤；那么PQ确认阶段需要进行3个限度，总共9次运行吗？还是只是进行正常批量一个中限的3次运行。
各位战友，这个问题是很难啊，还是很容易啊？
给个意见。
既然是做PQ，当然希望做到极限条件，比如灌封机，肯定要在最快速度和最慢速度时进行运行确认，考察设备的性能是否与说明书一致和运行稳定性情况。
个人认为，可以用替代或模拟产品做上限和下限的设备性能确认（6次），用正常生产产品（中限）进行工艺验证（3次，实际和性能确认合并一起做了）。
就象购买一台设备，是否说明书中的所有功能都需要确认，而所有功能中，平时使用的仅仅是2～3个。如果你有时间的话，当然所有的功能都要做，这样是对于购买设备的负责。