PCBAs Process Validation Help (Regulations FDA)

alonFAI

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#1
Hello Guys

I have a basic question regarding validation process.
I am about to validate a PCBA manufacturing process.
we manufacture these PCBAs in a 50 PCBAs tablet.


currently my validation procedures is 4,4,5. (3 batches)
when I am validate am I suppose to validate exactly the amount I'm gonna manufacture day to day? meaning if my basic manufacturing unit is a table of 50 PCBAs must I validate 50,50,50 instead of 4,4,5? (If I manufacture in the SMT machine 4 cards out of those 50 and throw away he rest of the tablet i use a certain program, but if I manufacture the whole 50 I use another program hence if I validate the process using one programming to the smt machine but on a daily basis I use another programming - 50 cards in a run, then I actually did not validate the actual process).

regulatory IF i validate a process where i manufacture batches of 50 at a time (tablet) that what I have to do on regular manufacturing? I.E I am no allowed to manufacture 20 out of the 50 table?

Hope I managed to be clear

thanks!!!:agree::applause::bigwave::eek::thanks:
 
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Vthouta

#3
Hi,

I'm unable to decipher the information on the validation. You state that

Currently my validation procedures is 4,4,5. (3 batches)
when I am validate am I suppose to validate exactly the amount I'm gonna manufacture day to day? meaning if my basic manufacturing unit is a table of 50 PCBAs must I validate 50,50,50 instead of 4,4,5? (If I manufacture in the SMT machine 4 cards out of those 50 and throw away he rest of the tablet i use a certain program, but if I manufacture the whole 50 I use another program hence if I validate the process using one programming to the smt machine but on a daily basis I use another programming - 50 cards in a run, then I actually did not validate the actual process).

How did you arrive 4,4,5 batches to validate?
Are you validating entire process at once? As you state that based on different batch orders on a given day, you do it differently? Did I understand your statement correctly?

Are you talking about the there 4 boards in a panel?

I'd like to help you, but its unclear on how you are validating?

Can you make it more clear, so that its easy to post the reply?

Thanks,
Vikram
 
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