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.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
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 -
Process (b)(4) validation evaluates the soundness of design and state of control of a process throughout its lifecycle.
FDA · FDA Warning Letter · 2024-07-16
