Can someone please help with this one:
If our packaging sub-contractor validated sealer machine broke down or was changed to a new one - except for machine qualification - would we need to perform packaging validation all over again?
Can someone please help with this one:
If our packaging sub-contractor validated sealer machine broke down or was changed to a new one - except for machine qualification - would we need to perform packaging validation all over again?
Yes.
New machine involves new installation qualification, and logically the next steps of operational and performance qualification follows. The new machine may be different to the broken down sealing machine, and hence the logical full re-validation.
If the machine was repaired with the appropriate spares without altering the specifications of the machine, an installation qualification would do. However a sound practice would be to have a full re-validation.
If its a like for like change ie. same brand and make of sealing machine, a simple qualification is required. However, if you change to a different model and make, a detailed equipment qualification is required.
Of course yes, if it is a new machine.
It depends, in case of machine breakdown, what and how in the machine was replaced / repaired, and made good to work.
To support our response, can you kindly tell us what was the nature of the machine breakdown ?
2. identify some Operational Qualification parameters that you feel are necessary for quality and safety like temperature verification, calibration and time verification. Also perform certain safety parameter verification (poka yoke) if you have on the Sealer.
3. perform a condensed Performance Qualification by testing end product to the spec like Leak Test.
You discussed the situation when a new sealer is installed. I performed the IQ, OQ and PQ for one sealer, but there are other two on the site. They are the same brand and model. Could you please advise: Should I perform the same tests as for the first sealer?
Is it possible to shorten the qualification process of the other two sealers? Do I have to perform all OQ tests again?
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