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How to handle a blood stained GMP document ?

D

DiceNa

#1
Is there anyone fimiliar with how to handle Bloodbourne issues when it comes to GMP documenation. For example...what to do if there is blood on an original GMP document.

We recently encountered a situation at my facility and I was told to put tape over the blood and that was sufficient. This is my first venture into a GMP facility, but this does not match how I would have handled this at previous employers.

I suggested that we copy the page with blood spots, santize the spots, provide a comment (in the event the page is damaged during sanitization) and retain the copy with the original document.

I was told this was excessive and not necessary and too risky as it might damage original documentation. I was more concerned about blood exposure to team members than the document.

Any insight would be helpful.
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#4
In all seriousness... if I was a customer and I saw this my first question would be how do I know that none of this blood contacted the product that this record was for? And if it did how did you take care of it? Is there an NCR documeneting actions, etc?

Do you have a bloodborne pathogens procedure?
I don't think putting tape over it is not OK - bloodborne pathogens is serious stuff for the FDA and for OSHA. I would recommend scanning or copying the record, destroy the original in accordance with BBP and document control procedures, file the copy as the record with a deviation explaining what happened.

I've been in these shoes in the printing for pharma and device business. A paper cut can cause all kinds of havok.
 

Wes Bucey

Prophet of Profit
#6
I also subscribe to Scott's solution. No way the blood should be retained. By the way, did you fill out all the proper documentation for treating the victim of the paper cut.

:topic:
Ironically, in our contract machining business, we had more first aid events among office personnel than shop folks. Shop folks had a lot of fail safe measures to prevent injury, but office folks seemed to slam fingers in file drawers, drop office machines on toes, burn themselves on hot parts of office machines, fall off chairs while leaning back, cut themselves with letter openers, choke on chewing gum, etc. at a rate that provoked rumors of "death wish" (only half joking.)
 
H

Hileen

#7
I agree with the above posters - also get a procedure in place what to do when similar incidents happen in future.

Attached is a generic SSOP for handling blood incidents in a plan - customize it for your use.

Hileen
 

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