Definition
Documented 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.
Related terms
ICH Q3C
The 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.
Extractables & Leachables
Extractables 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.
Stability Study
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.
Batch Release
The 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.
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