Process Validation: Successes and Failures on Inspection

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Process Validation: Successes and Failures on Inspection
WCBP 2005 January 10, 2005 WCBP 2005 January 10, 2005
Mary Malarkey, Mary Malarkey, Director, Director,
Office of Compliance and Biologics Quality Office of Compliance and Biologics Quality
Center For Biologics Evaluation and Research Center For Biologics Evaluation and Research U.S. Food and Drug Administration
After the conformance lots?
Routine monitoring of critical Routine monitoring of critical IPCs IPCs
Routine monitoring of critical equipment Routine monitoring of critical equipment parameters; preventive maintenance; parameters; preventive maintenance;
calibration calibration
Routine monitoring of environment; Routine monitoring of environment;
personnel (as applicable) personnel (as applicable)
Ongoing training activities Ongoing training activities
Quality Oversight
Complete report can be viewed online.