Scope of validation for identical machines

Hello all,

We have two equivalent machines to seal Tyvek pouches (sterile barrier). Same model, same type, same work instructions, users, environmental condition, calibration method etc.

Of course, we will do the IQ step for each system.
what about the OQ and PQ ? We plan to perform the OQ and PQ on one system, with a justification stating the machines are identical.

Does any standard support it? (Or vice versa - does any standard provide an answer to this issue?)

I would not repeat OQs, unless the process parameters are different for the different machines.

I would not repeat PQs when installing a second machine; I would expect that the same control plans are implemented on each machine. My instincts are to keep an eye on the variation between each machine as well, just in case there is a subtle source of variation between them.

If there are more than one identical machine being installed initially, I would incorporate each machine into the PQ... as the different machines are a potential source of variation that ought to be considered when creating control plans.

If you are not going to do a OQ or PQ, make sure to document the rationale, ideally with a risk assessment, as to why not. FDA are likely to look at this. However, I would run one PQ batch, just to show the second sealer can work reliably over an extended period. Sometimes its easier to just do the qualification than to argue with FDA as to why its not required.

Tidge said:

I would not repeat OQs, unless the process parameters are different for the different machines.

I would not repeat PQs when installing a second machine; I would expect that the same control plans are implemented on each machine. My instincts are to keep an eye on the variation between each machine as well, just in case there is a subtle source of variation between them.

If there are more than one identical machine being installed initially, I would incorporate each machine into the PQ... as the different machines are a potential source of variation that ought to be considered when creating control plans.

Click to expand...

Due consideration for the criticality of unit operations needs to be addressed; and from that perspective, in this case, it is a direct impact system;

It's difficult to justify, given that the performance of each piece of equipment is independent of each other; i.e., precision, defects, errors/alarms, the principle of operation could be the same; they are a function of configuration, and range of recipe ( product, materials, operating parameters) being addressed; hence therefore, it's only reasonable to cover the OQ challenges the range, alarms/errors/defects; and Yes, PQ could be common activity across machines.,

One approach is to identify the risks to verify the critical control points and let the other points be monitored comparatively for the differences.

Further, a specific question is the standard referencing handling of the above scenario;
I do not know any standard/guidance to my knowledge and understanding ( ISPE commissioning and qualifications );