Hi folks,
I’m QA Manager in a Pharma Distribution company. We have re-labeling dept. working within GMP frame. The labels are counted separately before use, we wanted to use a label counter (already existing but not used).
How I can perfom OQ\PQ - protocol? - for different label dimensions? The only adjustable operation is the counting speed, with a mechanical knob.
It is quite urgent.
Thank to all,
Milena
Hello Milena,
Your case is very specific and Unique.
If you look in the regulatory prespective you perform IQ only once.
You qualify the lable counter in the IQ.
[COLOR=“darkred”]Then comes the Different size of lables–There are 2 options
1.Do you have a single lable holder that is adjustable for Different Sizes of Lables?
Or
2.Do you have Different lable Holders for the machine for every different lable you use?[/color]
[COLOR=“sienna”]If your category falls under Point 1 then you straight away qualify the machine along with your lable counter in one shot. Since the lable holder is same abd adjustable you will perform IQ/OQ for different size of lables in one go based on the speeds.The only thing you have to do is that they will be qualified as Annexure-1, Annex-2 etc based
on lable sizes.[/color]
Now if your category falls under Point 2 here is the way you have to qualify:
[COLOR=“red”]Perform the IQ of the machne with all the First attachment in place. Then perform the OQ/PQ of the lable based on the dimension of the holder.
After finishing with the first size you will move to the second size and perform the qualification similar to your first run with second attachment[/color]
[COLOR=“blue”][b]Some points to be considered for all the above:
-Get a quality assurance clearence and acceptence of your lables.
-Write seperate SOP for installation of lable holders for Different sizes of lables–make sure you will number the SOP’s properly.
-Give the deviation limits of such lables (What I mean is dimension specifications).
-Perform runs for minimum and maximum out put speeds for all the runs, document them properly.
-Give the limits of rejections allowable based up on lables.
-Calibration procedure for lable Counter and Or control procedure of the same.[/b][/color]
Regards
Durga,
thanks a lot!
my case is point 1 - your details truly helped!
Best regards,
Milena
Welcome Milena.
I sincerely thank this forum , Moderator and all folks who post good questions like this.
This makes folks like me to really look deep into qualification procedures and give best advises to our ability.
We are all learning in this process.
Regards