Environmental Control and Developing a Science-based Monitoring Program. Richard L. Friedman, M.S. FDA/CDER. Aseptic Processing Line D/M. Process -personnel flow -material flow -layout. Facility & Room D/M. Personnel. D= Design M = Maintenance. QA/QC. Daily “Sterility
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Environmental Control and Developing a Science-based Monitoring Program
Richard L. Friedman, M.S.
M = Maintenance
2002 Concept Paper