Standard Operating Procedure for Monitoring Printing Inks Used in Packaging
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/241/2025 |
| Supersedes | SOP/TAB/241/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/06/2026 |
| Effective Date | 06/06/2026 |
| Review Date | 01/06/2027 |
1. Purpose
The purpose of this SOP is to ensure that printing inks used in the packaging of tablet products are monitored for quality, compliance with regulatory standards, and consistency in application.
2. Scope
This SOP applies to all printing inks used in the packaging of tablet products, including primary and secondary packaging. It covers the monitoring of ink quality, compliance with safety standards, and application checks during packaging operations.
3. Responsibilities
- Production Manager: Ensures that ink quality checks are conducted regularly and any issues are addressed promptly.
- Packaging Operators: Responsible for ensuring that the correct ink is used for each product packaging run and that the ink is applied according to specifications.
- Quality Control (QC) Inspector: Monitors the quality of inks, ensures regulatory compliance, and conducts ink testing as per this SOP.
- Maintenance Personnel: Maintains the equipment used for printing and ensures it is in proper working condition to avoid defects in printed packaging.
4. Accountability
The Production Manager is accountable for ensuring that the printing ink monitoring process is followed. The QC department is responsible for conducting ink quality checks and ensuring compliance with regulatory standards.
5. Procedure
5.1 Ink Receipt and Inspection
- Upon receipt of printing inks, inspect the ink containers for any damage during transportation (Annexure-1).
- Check the batch number and expiry date on the ink containers to ensure they are within acceptable limits (Annexure-2).
- Ensure that the ink is accompanied by a Certificate of Analysis (CoA) verifying compliance with regulatory standards (Annexure-3).
5.2 Ink Storage
- Store inks in a cool, dry area away from direct sunlight, heat sources, and moisture to preserve their quality (Annexure-4).
- Label storage areas clearly with the type of ink, batch number, and date of receipt (Annexure-5).
- Ensure that inks are stored in a manner that prevents cross-contamination or mixing of different ink types (Annexure-6).
5.3 Ink Usage and Application Monitoring
- Before each production run, verify that the correct ink type is selected and that it is compatible with the packaging material being used (Annexure-7).
- Monitor the application of the ink on the packaging materials during production. Ensure that the ink is applied evenly and without defects (e.g., smudging, fading) (Annexure-8).
- Periodically test the ink for compliance with color consistency, opacity, and adhesion to packaging materials (Annexure-9).
5.4 Ink Quality Checks
- Conduct ink quality checks at regular intervals during the production process. Inspect printed materials for clarity, uniformity, and legibility of text or images (Annexure-10).
- If any defects are identified (e.g., smudging, fading, incorrect color), halt the production line and identify the cause of the issue (Annexure-11).
- Correct any issues related to ink quality before continuing production (Annexure-12).
5.5 Ink Waste Management
- Ensure that any leftover or waste ink is disposed of according to environmental and safety guidelines (Annexure-13).
- Maintain records of ink usage and waste disposal to comply with regulatory and internal waste management policies (Annexure-14).
5.6 Documentation and Record-Keeping
- Maintain detailed records of all ink inspections, usage, and quality checks. Ensure that records are easily retrievable and traceable (Annexure-15).
- All ink-related documentation should be retained for the required retention period as per regulatory and company policies (Annexure-16).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CoA: Certificate of Analysis
7. Documents
- Ink Receipt Log (Annexure-1)
- Ink Batch Number and Expiry Log (Annexure-2)
- Certificate of Analysis (CoA) (Annexure-3)
- Ink Storage Log (Annexure-4)
- Ink Storage Area Labeling Log (Annexure-5)
- Ink Usage Log (Annexure-6)
- Ink Application Monitoring Log (Annexure-7)
- Ink Quality Check Log (Annexure-8)
- Defective Ink Report (Annexure-9)
- Corrective Action Log (Annexure-10)
- Waste Ink Disposal Log (Annexure-11)
- Ink Waste Management Log (Annexure-12)
- Ink Usage and Waste Records (Annexure-13)
- Ink Documentation Retention Log (Annexure-14)
- Final Ink Quality Check Log (Annexure-15)
- Ink Documentation Log (Annexure-16)
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: Ink Receipt Log
| Ink Type | Receipt Date | Supplier | Quantity Received | Batch Number |
|---|---|---|---|---|
| Blister Ink | 01/06/2026 | ABC Inks | 500 Liters | INK-12345 |
Annexure-2: Ink Batch Number and Expiry Log
| Batch Number | Expiry Date | Received Date | Operator |
|---|---|---|---|
| INK-12345 | 01/06/2027 | 01/06/2026 | John Doe |
Annexure-3: Certificate of Analysis (CoA)
| Ink Type | CoA Reference Number | Analysis Date | Supplier | Analysis Result |
|---|---|---|---|---|
| Blister Ink | COA-12345 | 01/06/2026 | ABC Inks | Pass |
Annexure-4: Ink Storage Log
| Ink Type | Storage Date | Storage Location | Quantity Stored | Storage Conditions |
|---|---|---|---|---|
| Blister Ink | 01/06/2026 | Warehouse A, Shelf 2 | 500 Liters | 15°C to 25°C, Dry |
Annexure-5: Ink Storage Area Labeling Log
| Ink Type | Labeling Date | Labeling Operator | Storage Location |
|---|---|---|---|
| Blister Ink | 01/06/2026 | John Doe | Warehouse A, Shelf 2 |
Annexure-6: Ink Usage Log
| Material | Usage Date | Batch Code | Quantity Used | Operator |
|---|---|---|---|---|
| Blister Ink | 02/06/2026 | INK-12345 | 50 Liters | Jane Smith |
Annexure-7: Ink Application Monitoring Log
| Material | Application Date | Operator | Application Result | Comments |
|---|---|---|---|---|
| Blister Ink | 02/06/2026 | John Doe | Pass | Ink applied uniformly |
Annexure-8: Ink Quality Check Log
| Material | Quality Check Date | Inspector | Quality Check Result | Action Taken |
|---|---|---|---|---|
| Blister Ink | 02/06/2026 | Jane Smith | Pass | No corrective action needed |
| Blister Ink | 02/06/2026 | John Doe | Fail (smudging) | Printer recalibrated |
Annexure-9: Defective Ink Report
| Material | Defect Type | Defect Description | Corrective Action Taken | Reported By |
|---|---|---|---|---|
| Blister Ink | Smudging | Ink smudged during application | Printer recalibrated | Jane Smith |
Annexure-10: Corrective Action Log
| Issue | Corrective Action Date | Corrective Action | Responsible Person |
|---|---|---|---|
| Ink smudging | 02/06/2026 | Recalibrate the printer | John Doe |
Annexure-11: Waste Ink Disposal Log
| Material | Disposal Date | Quantity Disposed | Disposed By | Disposal Method |
|---|---|---|---|---|
| Blister Ink | 03/06/2026 | 5 Liters | John Doe | Disposed according to safety guidelines |
Annexure-12: Ink Waste Management Log
| Material | Waste Type | Waste Quantity | Action Taken |
|---|---|---|---|
| Blister Ink | Ink Waste | 5 Liters | Properly disposed of |
Annexure-13: Ink Usage and Waste Records
| Material | Usage Date | Quantity Used | Quantity Wasted | Batch Code |
|---|---|---|---|---|
| Blister Ink | 02/06/2026 | 50 Liters | 2 Liters | INK-12345 |
Annexure-14: Ink Documentation Retention Log
| Document Type | Retention Period | Retention Start Date | Stored By |
|---|---|---|---|
| CoA for Blister Ink | 5 years | 01/06/2026 | Jane Smith |
Annexure-15: Final Ink Quality Check Log
| Material | Final Check Date | Inspector | Final Check Result | Comments |
|---|---|---|---|---|
| Blister Ink | 03/06/2026 | John Doe | Pass | Ink quality verified |
16. 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 |
| 01/06/2025 | 2.0 | Updated ink quality checks and waste management procedures | Process optimization | QA Head |