Keep Rejected and Approved Labels Separately Stored in GMP Facilities

Segregate Rejected Labels from Approved Ones to Prevent Mix-Ups

Remember: Never store rejected labels in the same area as approved labels — this poses a serious risk of mislabeling and regulatory non-compliance.

Why This Matters in GMP

Labels are essential to product identity, traceability, and regulatory compliance. Rejected labels — due to print errors, outdated information, or color mismatches — must be strictly separated from approved labels to avoid accidental use. Even a single mislabeled unit can result in a batch recall, product confusion, or severe patient safety risk.

For instance, if labels for 250 mg tablets are mistakenly affixed to 500 mg packs due to poor segregation, patients may be under- or overdosed. GMP systems must treat label control with the same rigor as product testing or batch release. Proper storage, handling, and destruction of rejected labels are foundational to avoiding costly labeling deviations and regulatory scrutiny.

Also Read: Never Initiate Cleaning with Expired Disinfectants in GMP Facilities

Regulatory and Compliance Implications

21 CFR Part 211.130 mandates strict control over labeling operations, including storage and issuance. EU GMP Chapter 5 requires clear segregation of materials to prevent mix-ups. WHO GMP also specifies that labels must be controlled, and any rejected labels must be destroyed or

stored securely and separately to avoid re-use.

Auditors inspect labeling rooms, storage areas, and reconciliation logs. Finding rejected labels near active inventory or in unmarked bins is a major compliance breach. These violations often result in observations related to inadequate line clearance, material mix-up control, and lack of SOP enforcement.

Implementation Best Practices

Designate clearly labeled, locked storage areas or bins for rejected labels. Maintain rejection logs that include label type, quantity, reason for rejection, and QA approval. Ensure that destruction or return-to-vendor steps are documented and verified. Use color-coded tags to visually differentiate approved vs. rejected materials.

Also Read: Use Only Validated Autoclaves for Sterile Component Preparation

Train packaging and warehouse personnel in label handling protocols. Include label segregation as part of GMP refresher training and mock recall exercises. Audit label control practices routinely and escalate any deviation from segregation SOPs.

Regulatory References

– 21 CFR Part 211.130 – Packaging and labeling control
– EU GMP Chapter 5 – Production
– WHO TRS 961, Annex 6 – Labeling and packaging practices
– PIC/S PI 006 – Good Practices for Label Management