Procedure for Verifying Labeling Accuracy
| Department | Quality Control (QC)/Production/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/078 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for verifying labeling accuracy in ointment packaging. Proper labeling ensures compliance with regulatory requirements and prevents mix-ups, misbranding, and incorrect product identification.
2. Scope
This SOP applies to all personnel in the Production, Quality Control (QC), and Quality Assurance (QA) departments responsible for inspecting and verifying the accuracy of labels on ointment containers before batch release.
3. Responsibilities
- Production Operator: Ensures labels are applied correctly and match the product specifications.
- Production Supervisor: Monitors in-process labeling verification and resolves any issues.
- Quality Control Analyst: Conducts random label accuracy checks and records observations.
- Quality Assurance (QA) Personnel: Reviews and approves labeling documentation before product release.
4. Accountability
The Production, QC, and QA Managers are accountable for ensuring that labeling accuracy is verified and documented as per GMP and regulatory requirements.
5. Procedure
5.1 Equipment and Materials
- Automatic or semi-automatic labeling machine
- Barcode scanner (if applicable)
- Labeling specification sheet
- Reference sample of approved label
- Batch Manufacturing Record (BMR)
- Label Verification Log
5.2 Pre-Labeling Checks
- Ensure that the correct labels are used for the batch.
- Verify label content against the approved label specification.
- Check that the label printer is functioning correctly.
- Perform a trial label application on a dummy container before starting production.
5.3 In-Process Labeling Verification
5.3.1 Visual Inspection
- Inspect labels for legibility, clarity, and correctness.
- Ensure that batch number, expiry date, and manufacturing details are printed correctly.
- Check for smudging, misalignment, or label peeling.
5.3.2 Barcode and Serial Number Verification (if applicable)
- Scan the barcode on randomly selected units.
- Ensure the barcode matches the product database.
- Verify that serialization numbers are unique and properly recorded.
5.3.3 Random Sampling
- Collect a defined number of units (e.g., 10 per 1000 units) for label verification.
- Cross-check label details with the approved reference sample.
- Document any discrepancies and notify the Production Supervisor immediately.
5.4 Corrective Actions for Labeling Errors
- If a labeling error is detected, halt the labeling process immediately.
- Remove affected units from production.
- Identify the root cause (e.g., printer malfunction, incorrect roll of labels).
- Reprint and reapply labels as needed.
- Perform additional checks before resuming production.
5.5 Acceptance Criteria
- All printed details (batch number, expiry date, barcode, etc.) must be legible and match the BMR.
- Labels must be applied straight, without wrinkles, air bubbles, or misalignment.
- Any batch with more than 1% labeling defects must undergo full batch inspection.
5.6 Post-Labeling Verification
- Perform final visual inspection of labeled units before batch release.
- Ensure any rejected units have been properly documented and removed.
- QA personnel must review and approve the Label Verification Log.
5.7 Documentation
- Record all label verification results in the Label Verification Log.
- Document all corrective actions if labeling deviations occur.
- Ensure traceability by maintaining batch-wise records.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Label Verification Log (Annexure-1)
- Final Batch Labeling Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <17> – Prescription Container Labeling
- ICH Q8 – Pharmaceutical Development
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Label Verification Log
| Date | Batch Number | Sample ID | Checked By | Defects Observed | Action Taken | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | SMP-001 | QA Officer | None | Approved | QA Supervisor |
| 01/02/2025 | OINT-102 | SMP-002 | QA Officer | Smudged text | Label Reprinted | QA Supervisor |
Annexure-2: Final Batch Labeling Report
| Date | Batch Number | Label Verification | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Checked | No defects | Pass | Approved | QA Head |
| 01/02/2025 | OINT-102 | Checked | No defects | Pass | Approved | QA Head |