Glossary
State of Control
The condition in which the set of controls in use provides continued assurance that process performance and product quality remain suitable.
Source · ICH Q10, Glossary, State of Control
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your QU lacked adequate oversight and control over your laboratory operations to ensure a state of control and adherence to applicable quality standards.
FDA · FDA Warning Letter · 2026-10-13 -
Your QU lacked adequate oversight and control over your OTC drug product manufacturing operations to ensure state of control and adherence to all quality standards.
FDA · FDA Warning Letter · 2026-06-02 -
This rate is excessive and calls into question the state of control of your process.
FDA · FDA Warning Letter · 2025-01-21
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q10, Glossary, State of ControlGRM Regulatory Glossary
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