Blood Component Making Validation Process

[nsfirm 11]

Dear all,

I have to do validation process for the blood component making for each components that we made. But so many things still made me confused.

1. How many blood bags should be used for validation process? Is there any rules of how to calculate it?

2. Is it possible to do it more than one times? e.g. when I need to validate 60 blood bags, can we do it in three parts, each 20 blood bags?

I asked the second question because in my country, the auditor said that we have to do it three times (because according to Pharmaceutical GMP, we have to do it three times). But when I ask about how many and how, it just answered by there is no certain rule about it.

3. Do we have to do it three times? e.g. when I need to validate 60 blood bags, do we have to do 3 x 60 blood bags instead of 1 x 60 blood bags or like question number two, 3 x 20 blood bags?

So, how do you do it in your place?

Thank you.