Standard Operating Procedure for Ensuring Compliance with Packaging Label Requirements
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/247/2025 |
| Supersedes | SOP/TAB/247/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to ensure that packaging labels comply with regulatory requirements and company standards. This procedure outlines the steps for verifying that all required information is clearly visible, accurate, and compliant with the labeling guidelines before products are released for distribution.
2. Scope
This SOP applies to all tablets being packaged at the manufacturing site, including both primary and secondary packaging. It covers the label content verification process to ensure compliance with regulatory authorities such as the FDA, EMA, or other relevant bodies.
3. Responsibilities
- Packaging Operators: Responsible for applying the labels correctly during packaging, ensuring that the labels are consistent with the approved design.
- Quality Control (QC): Ensures that the packaging labels meet all required regulatory and internal standards before products are released for sale or distribution.
- Regulatory Affairs: Responsible for ensuring that all labeling complies with the latest regulatory requirements.
- Production Manager: Oversees the overall compliance process to ensure that the packaging label requirements are met consistently across all production batches.
4. Accountability
The Production Manager is accountable for ensuring that the packaging labeling process follows the prescribed SOP. Any discrepancies found during labeling must be documented and corrected in a timely manner.
5. Procedure
5.1 Review of Labeling Specifications
- Before production begins, review the approved label design for compliance with regulatory requirements and company standards (Annexure-1).
- Verify that the label includes all necessary information such as product name, batch number, expiry date, dosage form, storage instructions, and any applicable warnings (Annexure-2).
- Ensure that the font size, color, and placement are consistent with company guidelines and regulatory requirements (Annexure-3).
5.2 Label Printing
- Verify that the correct labels are printed for the correct batch number and production date (Annexure-4).
- Check that the label printing equipment is calibrated and functioning properly before the start of each production run (Annexure-5).
- Ensure that printed labels match the approved design and do not contain any errors such as missing information or incorrect fonts (Annexure-6).
5.3 Label Application
- Ensure that the labels are applied correctly to the products, ensuring proper alignment, legibility, and adherence to the packaging surface (Annexure-7).
- Verify that the correct labeling is applied to each packaging unit (e.g., blister pack, bottle, carton) according to the product specifications (Annexure-8).
- If any label is misapplied or incorrectly printed, document the issue and discard the affected units (Annexure-9).
5.4 Label Verification
- QC will perform a final check of the labels on a sample of products from each batch to ensure that all required information is present and correct (Annexure-10).
- Verify that the labels are clear, legible, and properly placed, following all specifications from the label design (Annexure-11).
- If any discrepancies are found, return the packaging to the production line for corrective action (Annexure-12).
5.5 Documentation and Record-Keeping
- Document all label checks and verifications in the Labeling Verification Log (Annexure-13).
- Keep all records for a minimum of two years or as required by regulatory authorities (Annexure-14).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
7. Documents
- Label Design Approval Form (Annexure-1)
- Labeling Specifications (Annexure-2)
- Label Font and Design Standards (Annexure-3)
- Label Printing Log (Annexure-4)
- Printing Equipment Calibration Log (Annexure-5)
- Label Print Verification Log (Annexure-6)
- Label Application Check Log (Annexure-7)
- Product Labeling Verification Log (Annexure-8)
- Label Misapplication Record (Annexure-9)
- Label Verification Log (Annexure-10)
- Labeling Discrepancy Report (Annexure-11)
- Labeling Issue Report (Annexure-12)
- Labeling Documentation Log (Annexure-13)
- Packaging Records Retention Log (Annexure-14)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- 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 Design Approval Form
| Design Version | Approval Date | Approved By |
|---|---|---|
| V1.0 | 01/07/2026 | John Doe |
Annexure-2: Labeling Specifications
| Specification | Required Value | Actual Value | Comments |
|---|---|---|---|
| Font Size | 12 pt | 12 pt | Compliant |
Annexure-3: Label Font and Design Standards
| Specification | Required Value | Actual Value | Comments |
|---|---|---|---|
| Font Type | Arial | Arial | Compliant |
| Font Color | Black | Black | Compliant |
Annexure-4: Label Printing Log
| Batch Number | Printing Date | Operator | Label Type | Printing Status |
|---|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Blister Pack Labels | Completed |
Annexure-5: Printing Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Status |
|---|---|---|---|
| Printer 001 | 01/07/2026 | Jane Smith | Pass |
Annexure-6: Label Print Verification Log
| Batch Number | Verification Date | Verified By | Verification Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Compliant |
Annexure-7: Label Application Check Log
| Product Name | Label Applied By | Check Date | Check Status |
|---|---|---|---|
| Tablet A | Jane Smith | 01/07/2026 | Compliant |
Annexure-8: Product Labeling Verification Log
| Product Name | Verification Date | Verified By | Verification Status |
|---|---|---|---|
| Tablet A | 01/07/2026 | John Doe | Pass |
Annexure-9: Label Misapplication Record
| Batch Number | Misapplication Date | Issue Description | Corrective Action |
|---|---|---|---|
| Batch 12345 | 02/07/2026 | Wrong label applied | Re-applied correct label |
Annexure-10: Label Verification Log
| Product Name | Verification Date | Verified By | Status |
|---|---|---|---|
| Tablet A | 01/07/2026 | Jane Smith | Compliant |
Annexure-11: Labeling Discrepancy Report
| Issue Description | Discrepancy Date | Corrective Action | Resolved By |
|---|---|---|---|
| Missing batch number | 02/07/2026 | Reprinted and applied corrected labels | John Doe |
Annexure-12: Labeling Issue Report
| Issue Description | Reported By | Report Date | Action Taken |
|---|---|---|---|
| Incorrect label font size | Jane Smith | 02/07/2026 | Font size corrected in production |
Annexure-13: Labeling Documentation Log
| Document Type | Document Reference Number | Document Date |
|---|---|---|
| Label Verification Report | LV-12345 | 01/07/2026 |
Annexure-14: Packaging Records Retention Log
| Material Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Labels | 5 years | John Doe | Storage Area B |
15. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/07/2026 | 2.0 | Updated label application procedure and documentation | Process optimization and added new corrective actions for labeling issues | QA Head |