Procedure for Verifying Labels During Aerosol Packing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/178/2025 |
| Supersedes | SOP/Aerosol/178/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for verifying labels on aerosol products during packaging. Proper label verification ensures product identification, regulatory compliance, and prevention of labeling errors.
2. Scope
This SOP applies to all aerosol products undergoing label application and verification before packaging, ensuring correctness in batch details, expiry dates, barcodes, and product information.
3. Responsibilities
- Packaging Operators: Responsible for verifying and applying labels accurately.
- Quality Assurance (QA) Team: Responsible for performing periodic label verification checks.
- Production Supervisor: Responsible for monitoring labeling operations and ensuring compliance.
- Regulatory Affairs Team: Responsible for ensuring label content complies with regulatory requirements.
4. Accountability
The Packaging Manager is accountable for ensuring that labels on aerosol products meet regulatory and company standards.
5. Procedure
5.1. Pre-Labeling Verification
- Ensure that label artwork has been approved by Regulatory Affairs.
- Cross-check label specifications with the Label Specification Sheet (Annexure-1).
- Inspect the printing quality and clarity of labels.
5.2. Label Application Process
- Ensure the correct label roll is loaded into the label applicator.
- Verify the label alignment on the first five containers.
- Conduct routine checks every 30 minutes during production.
- Record label verification results in
the Label Verification Log (Annexure-2).
5.3. Barcode and Batch Code Verification
- Verify that the barcode scans correctly and matches the product database.
- Ensure batch coding includes:
- Batch Number
- Manufacturing Date
- Expiry Date
- Record all findings in the Barcode and Batch Code Log (Annexure-3).
5.4. Handling Labeling Errors
- Identify incorrect or misaligned labels and remove defective units.
- Record labeling errors in the Label Error Log (Annexure-4).
- Investigate repeated errors and implement corrective actions.
5.5. Post-Labeling Verification
- Perform a final inspection on a random sample of labeled units.
- Ensure all labeled units are correctly placed in secondary packaging.
- QA personnel must approve and sign off on the Label Verification Checklist (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- SKU: Stock Keeping Unit
7. Documents
- Label Specification Sheet (Annexure-1)
- Label Verification Log (Annexure-2)
- Barcode and Batch Code Log (Annexure-3)
- Label Error Log (Annexure-4)
- Label Verification Checklist (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- FDA Labeling Requirements for Aerosol Products
- ISO 9001 – Quality Management Systems
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 Specification Sheet
| Product Name | Label Dimensions | Regulatory Approval |
|---|---|---|
| Aerosol Spray X | 50 mm x 100 mm | Approved |
Annexure-2: Label Verification Log
| Batch No. | Verification Date | Checked By | Status |
|---|---|---|---|
| BN-123 | 07/02/2025 | Ramesh Kumar | Pass |
Annexure-3: Barcode and Batch Code Log
| Batch No. | Barcode Scan Result | Batch Code Correctness | Verified By |
|---|---|---|---|
| BN-124 | Scanned Successfully | Correct | Priya Sharma |
Annexure-4: Label Error Log
| Error Type | Batch No. | Occurrence Rate | Corrective Action |
|---|---|---|---|
| Misaligned Label | BN-125 | 1% | Recalibrated label applicator |
Annexure-5: Label Verification Checklist
| Checklist Item | Checked By | Verification Date | Status |
|---|---|---|---|
| Label Placement | Amit Sharma | 08/02/2025 | Pass |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated label verification process | GMP Compliance | Anjali Sharma |