SOP Guide for Pharma

Tablets: SOP for Monitoring Printing Inks Used in Packaging – V 2.0

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Tablets: SOP for Monitoring Printing Inks Used in Packaging – V 2.0

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

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

  1. Upon receipt of printing inks, inspect the ink containers for any damage during transportation (Annexure-1).
  2. Check the batch number and expiry date on the ink containers to ensure they are within acceptable limits (Annexure-2).
  3. Ensure that the ink is accompanied by a Certificate of Analysis (CoA) verifying compliance with regulatory standards (Annexure-3).
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5.2 Ink Storage

  1. Store inks in a cool, dry area away from direct sunlight, heat sources, and moisture to preserve their quality (Annexure-4).
  2. Label storage areas clearly with the type of ink, batch number, and date of receipt (Annexure-5).
  3. 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

  1. 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).
  2. 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).
  3. Periodically test the ink for compliance with color consistency, opacity, and adhesion to packaging materials (Annexure-9).

5.4 Ink Quality Checks

  1. 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).
  2. If any defects are identified (e.g., smudging, fading, incorrect color), halt the production line and identify the cause of the issue (Annexure-11).
  3. Correct any issues related to ink quality before continuing production (Annexure-12).

5.5 Ink Waste Management

  1. Ensure that any leftover or waste ink is disposed of according to environmental and safety guidelines (Annexure-13).
  2. 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

  1. Maintain detailed records of all ink inspections, usage, and quality checks. Ensure that records are easily retrievable and traceable (Annexure-15).
  2. All ink-related documentation should be retained for the required retention period as per regulatory and company policies (Annexure-16).

6. Abbreviations

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7. Documents

  1. Ink Receipt Log (Annexure-1)
  2. Ink Batch Number and Expiry Log (Annexure-2)
  3. Certificate of Analysis (CoA) (Annexure-3)
  4. Ink Storage Log (Annexure-4)
  5. Ink Storage Area Labeling Log (Annexure-5)
  6. Ink Usage Log (Annexure-6)
  7. Ink Application Monitoring Log (Annexure-7)
  8. Ink Quality Check Log (Annexure-8)
  9. Defective Ink Report (Annexure-9)
  10. Corrective Action Log (Annexure-10)
  11. Waste Ink Disposal Log (Annexure-11)
  12. Ink Waste Management Log (Annexure-12)
  13. Ink Usage and Waste Records (Annexure-13)
  14. Ink Documentation Retention Log (Annexure-14)
  15. Final Ink Quality Check Log (Annexure-15)
  16. Ink Documentation Log (Annexure-16)

8. References

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
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