Chapter Overview

This chapter will introduce deviation or nonconformance investigations, a hot topic for 2023. 

Deviations are states of non-compliance that might impact the manufacturing, packaging, testing, distribution, or storage of drug products. 

There is little wording or guidance in the direct primary legislation. Still, non-binding documents such as FDA Guidance for Industry and EU regulators Q&A documents often contain information on how to proceed. 

The investigation process requires the person responsible to accurately describe the deviation clearly and concisely using questioning techniques, gather as much data as possible, select appropriate tools to investigate root causes, and determine and implement effective CAPAs that are SMART (specific, measurable, aligned, realistic, and time-bound).