Missing detector in blister packaging machine

(Tri Nguyen) #1

Hello experts,

We have set up a new missing detector for an old blister packaging machine. Do we need to carry out performance qualification in this case? What parameters should be considered in the qualification?

Thank you.

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(Md.Asif Hussain) #2

Dear,
What I understand, it mean new camera is installed…

So, IQ,OQ and PQ shall be carried out as new revision to previous document, for this part of whole blister machine.
All challenge test should be covered- Rejection in case of Empty packet, broken tablet, black spot, different color product, different tablets, splices with all the speeds like minimum, maximum, optimum

Thanks

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(Tri Nguyen) #3

Thank you for the answer. Can I ask you one more question?
How can we carry out the qualification? I mean, will the qualification be carried out on routine batch? Or will we use the placebo tablets?

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(ussidaho) #4

OQ in practical mean to take dry runs testing (empty) or practice run testing or with a non-product= placebo load, ), dry run” test of a jet’s new pilot ejection seat while the jet is parked on the ground, rather than while it is in flight and its pilot (validation)=In army lingo this is a “dry run” — a trial without ammunition.
FDA’s new guidance indicates similar activities for OQ: “…This should include challenging the equipment or system functions while under load similar to that expected during routine production.”
For PQ you may use the relevant product (a real product) and carry out the test just in the normal condition.

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