Sterility assurance programs must be complex and multilayered if they are to reduce contamination risks in cleanrooms. They also must take "strict" approaches that follow both EU Annex 1 and USP Chapter 1116 guidelines if they are to pass muster with inspectors for global distribution.
This was the advice imparted by Marcia Baroni, director of QC microbiology and environmental monitoring and sterility assurance for Eli...
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