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Field Guide/Pharmaceutical Manufacturing Operations

Pharmaceutical Manufacturing Operations

Operational leadership, performance management, and execution discipline in pharmaceutical and batch-based manufacturing environments.

What is a GMP Deviation Investigation?

What is a GMP Deviation Investigation?

August 26, 2023 • By Mike Barlow

In GMP pharmaceutical production, including biologics and cell therapy manufacturing, a GMP Deviation Investigation is the structured process used to identify, document, analyze, and resolve any unexpected events or conditions that do not comply with approved procedures, specifications, or regulatory requirements.