---
title: "Stability Study — Definition | QbD Group"
description: "A study following ICH conditions that measures how a product's quality attributes change over time under defined temperature and humidity, establishing..."
url: https://qbdgroup.com/en/knowledge-center/glossary/stability-study
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Stability Study — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/stability-study"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# Stability Study

CMC & Manufacturing

## Definition

A study following ICH conditions that measures how a product's quality attributes change over time under defined temperature and humidity, establishing the retest period or shelf life and the recommended storage conditions.

## Related terms

[CSVDocumented evidence that a computerised system used in a GxP process consistently does what it is specified to do. It covers requirements, risk assessment, supplier assessment, testing, data integrity, and controls under EU GMP Annex 11 and 21 CFR Part 11.](https://qbdgroup.com/en/knowledge-center/glossary/csv)[ICH Q3CThe ICH guideline on residual solvents in pharmaceuticals. It classifies solvents by toxicity, sets permitted daily exposures and concentration limits, and underpins the analytical control strategy, typically by gas chromatography.](https://qbdgroup.com/en/knowledge-center/glossary/ich-q3c)[Extractables & LeachablesExtractables are compounds that can be drawn out of a container, device, or manufacturing material under exaggerated conditions; leachables are those that actually migrate into the product in normal use. Both are studied to support patient safety assessments.](https://qbdgroup.com/en/knowledge-center/glossary/extractables-and-leachables)[Batch ReleaseThe formal decision that a manufactured batch may be supplied. It follows review of the batch record, deviations, and test results, and in the EU requires certification by a Qualified Person against GMP and the marketing authorisation.](https://qbdgroup.com/en/knowledge-center/glossary/batch-release)

## Need more than a definition?

Our regulatory, quality, and clinical specialists turn these requirements into working submissions, systems, and studies.

[Explore our services](https://qbdgroup.com/en/services)[Talk to an expert](https://qbdgroup.com/en/contact)

---

Source: https://qbdgroup.com/en/knowledge-center/glossary/stability-study — © QbD Group. Quote freely with attribution and a link back.