Laboratory Investigation of Out-of-Specification (OOS) and Out-of-Trend (OOT) Results

What this document is for

The integrity of analytical data is the fundamental pillar of current Good Manufacturing Practices (cGMP). Standardizing the investigation of unexpected laboratory results is a strategic imperative to ensure that data is not only accurate but also representative of true product quality.

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Ships as

Grounded in

FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.

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