Never Mix Product Labels from Different Batches in the Packaging Area

Prevent Mixing of Product Labels in Packaging Rooms

Remember: Never allow different product or batch labels to coexist in the same packaging area — always ensure strict segregation.

Why This Matters in GMP

Packaging is a critical control point in pharmaceutical manufacturing, and label mix-ups can have catastrophic consequences. If labels for different products or batches are mixed, there is a significant risk of mislabeling, which can lead to incorrect drug dispensing, patient harm, and product recalls. This is a serious breach of GMP, traceability, and safety. Mixing of labels often results from poor line clearance, inadequate supervision, or failure to segregate materials. GMP expects a one-product, one-label policy per packaging line. Ensuring the physical and procedural segregation of labels prevents errors and reinforces batch identity throughout the packaging lifecycle.

Also Read: How to Integrate ANVISA GMP Guidelines into Your Pharmaceutical QMS

Regulatory and Compliance Implications

FDA 21 CFR Part 211.130 mandates control procedures for labeling and packaging operations to prevent mix-ups. EU GMP Annex 15 and WHO GMP require documented label reconciliation and line clearance practices. Schedule M also enforces strict label control and segregation. Failure to segregate labels has resulted in FDA warning letters and MHRA deficiency reports citing serious GMP lapses. Regulatory authorities expect visual inspections, reconciliation checks, and electronic or manual verification of labels. Non-compliance can trigger recalls, consent decrees, or import alerts. Effective label management is non-negotiable in any GMP packaging environment.

Implementation Best Practices

Enforce a line clearance checklist that confirms label area is free of unrelated items before starting packaging.
Use color-coded bins or label holders to segregate batches clearly.
Implement double verification of label batch numbers by QA and production personnel.
Establish label reconciliation logs and review them after every batch packaging run.
Install CCTV or barcode systems for electronic label confirmation if feasible.

Also Read: Conduct Risk Assessments Before Implementing Process Changes

Regulatory References

FDA 21 CFR Part 211.130 – Packaging and Labeling Operations
EU GMP Annex 15 – Qualification and Validation
WHO GMP – Labeling and Packaging Practices
Schedule M – Labeling and Packaging Control