Todd,
I would not recommend to do so. Experience has proven that a "simple" change of process or supplier - even if "everything" is supposed to be the same after the change may have an effect on biological safety.
I suggest that you set up your procedure hand in hand with your risk management and evaluate potential risks that arrise from changes in your risk assessment. Then, this will or will not have an effect on re-evaluation of biological safety - based on the risks.
Hope this helps.
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de -------------------------------------------
Original Message:
Sent: 07-03-2013 11:37
From: Todd Moore
Subject: Biological Evaluation
Looking for recommendations on how to word a Biological Evaluation procedure, in such a way that potential Supplier and Process changes are addressed on the initial evaluation. (To help limit or prevent the need for re-evaluation of the same material in the future.)
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Todd Moore
Palmyra VA
United States
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