GMP Deviation Management and CAPA Effectiveness: Closing the Loop Between 483 Observations and Systemic Fixes
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A batch fails a routine in-process check at 2 a.m. on a Saturday. The operator logs it, production pauses, and by Monday morning, a deviation record exists somewhere between a shift log and a quality email inbox. Six months later, the same failure mode reappears on a different line, and an FDA investigator asks a […]
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