US FDA
21 CFR 211.105 - Equipment Identification
Plain-language explanation, inspection context and common violation patterns.
What it says
Major equipment must be identified with a distinctive identification number or code, and where appropriate, the status of the equipment, such as clean, dirty or in-use for a specific product, must be indicated by a status label or equivalent system to prevent mix-ups.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Equipment status labeling is a real-time visual control preventing the specific error of using uncleaned equipment, or using equipment currently dedicated to a different product, not just a record-keeping formality.
- This provision works together with the equipment use log under 211.182, with the status label providing the immediate, at-a-glance control and the log providing the retrospective documented history.
- For facilities running multiple products on shared equipment, status labeling accuracy is directly tied to cross-contamination and mix-up prevention in practice, not just on paper.
What FDA inspectors look for
- Whether equipment status labels observed during a facility walkthrough accurately reflect the equipment's actual current status.
- Whether a status labeling system exists and is consistently used across all major equipment, not applied inconsistently between areas.
- Whether personnel understand and correctly interpret the status labeling system when interviewed.
Most common violation
Equipment status labels that are outdated, illegible or inconsistent with the equipment's actual condition, discovered during a facility walkthrough rather than through the site's own internal checks.
Want a deeper, interactive breakdown?
GMPify's Regulation Explainer tool gives subscribers an AI-powered analysis of any 21 CFR, EU GMP, USP or ICH reference, with live inspection context.
Try the Regulation Explainer →