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Blood Component Making Validation Process


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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.

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  • 2 months later...

I think you have to start by determining what components you are making.   Then you have to find the standards for that component in your country -  for example, in the USA if you are making packed red blood cells, when you QC your products, 75% of those tested have to have a hematocrit of </= 80%.  You then have to determine how much centrifugation you need to accomplish that efficiently.  When you are happy with your process you will need to perform QC on a routine basis (monthly, Quarterly - check your country's requirements).

Packed cells are probably the easiest to  make (except for additive solution red cells).  Platelet concentrates take a great deal of time. 

I recommend obtaining a copy of the AABB Technical Manual.  This should provide the information you require for all component prep and QA/QC.    Very labor intensive depending on what you are making.

Good luck.


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  • 2 years later...

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