PQ Validation Next

We just had a piece of equipment IQ and OQ validated yesterday. I know need to perform the PQ, but have no idea how to do so. I was also told that for every different product on the same machine, I have to perform a NEW PQ. Does anyone have any info on that and any help on where I might find info on how to create a template for a PQ and anything else that might help. After I get this one done, I am to complete the IQ/OQ/PQ validations for all the other pieces of equipment we have that have never been validated.

Thanks,

Lisa

Hi Lisa,

it would help if you told us what equipment it is.

The equipment is a Buflovak 40 CU FT Twin Shell Blender. I feel if I can understand how to do the PQ, and using the info from the IQ/OQ, then I should be able to put together the whole set for the rest of the equipment, which are two stick pack machines, a powder fill machine, and an encapsulation machine.

Thanks for any help you can offer.

Lisa

[quote=unekme]The equipment is a Buflovak 40 CU FT Twin Shell Blender. I feel if I can understand how to do the PQ, and using the info from the IQ/OQ, then I should be able to put together the whole set for the rest of the equipment, which are two stick pack machines, a powder fill machine, and an encapsulation machine.

Thanks for any help you can offer.

Lisa[/quote]

Create a set of scripts - as if it was being used in production. You should know exactly what the outputs should be based on the inputs so use these as your pass / fail criteria. PQ is testing the system as if it were in a live production environment - rather than like OQ which is normally in a test environment - the PQ has more “user testing” (if you like) rather than “functional OQ testing”. By the time we get to PQ, we already know the system functions correctly, so we just need to test it in a live environment using real products with the actual SOPs and standards/protocols etc. I hope that helps - it’s not easy to explain on a forum :slight_smile:

Sorry for the late reply too - I’ve been travelling so didn’t get home until very late. If you need any other help, just post back - I’ll tend to come on here every so often.

:slight_smile: