Glossary

Range

The interval between the upper and lower amounts over which an analytical procedure shows suitable precision, accuracy, and linearity.

Related sections

Findings from regulators' inspection documents in which this term appears.

As such, you have not provided scientific evidence to demonstrate that the wide ranges of airflow velocities generated by your HEPA filters do not adversely impact the airflow patterns inside your ISO 5 classified critical areas.
FDA · FDA Warning Letter · 2024-10-22
Laboratory equipment used for analytical testing was used outside ofthe calibrated range.
FDA · FDA 483 · 2017-05-11
Process Parameters (PPs) are not adequately controlled within established ranges iDCb><4> DS manufacturing process.
FDA · FDA 483 · 2026-04-24

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

GRM Regulatory Glossary

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