Tag: Deviations

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Complaint management and investigation in GMP focusing on risk-based governance, escalation, CAPA linkage, and compliance oversight.

Complaints Management in the Pharmaceutical Industry

Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs....
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FDA Warning Letter Analysis: Catalent Indiana, LLC

This FDA Warning Letter analysis examines how weak investigations, ineffective contamination control strategies, and batch-release-driven decision making allowed contamination risks...
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Deviation Management Process in GMP

Explore the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality...

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