Regulatory Open Forum

 View Only

Biological Evaluation - Changes to Supplier / Process

  • 1.  Biological Evaluation - Changes to Supplier / Process

    Posted 12-Jul-2013 09:54
    What would be the best way to word an internal Biological Evaluation Procedure, in order to put a company in the best position to handle eventual changes to Supplier or Process by writing justifications, vs. having to retest materials?

    Any thoughts or ideas on this would be much appreciated.  

    -------------------------------------------
    Todd Moore
    Palmyra VA
    United States
    -------------------------------------------