21 CFR 211.130 - Packaging and Label Operations

What it says

Written procedures must be established for packaging and labeling operations designed to ensure correct labels, labeling and packaging materials are used, including physical or spatial separation from operations on other products, and identification and handling of filled drug product containers set aside and held in unlabeled condition.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Physical or spatial separation between concurrent packaging operations on different products is an explicit expectation, not simply a best practice - line clearance procedures exist specifically to satisfy this.
• Unlabeled, filled containers held for later labeling represent a specific, named risk category this provision addresses directly, since a filled but unlabeled container is especially vulnerable to mix-up.
• Line clearance before a new packaging run begins is where this provision is most directly demonstrated in practice, verifying the previous product's materials have been fully cleared.

What FDA inspectors look for

• Whether documented line clearance is performed and verified before each new packaging run begins, with evidence the previous product's labels and materials were fully removed.
• Whether unlabeled, filled containers awaiting labeling are identified, controlled and traceable back to their specific batch during the hold period.
• Whether physical separation between simultaneous packaging operations for different products is genuinely maintained, not just described in procedure.

Related regulations