Standard Operating Procedure for Primary and Secondary Packing of Tablets

Department	Tablet
SOP No.	SOP/TAB/238/2025
Supersedes	SOP/TAB/238/2022
Page No.	Page 1 of 6
Issue Date	01/04/2026
Effective Date	06/04/2026
Review Date	01/04/2027

1. Purpose

This SOP outlines the procedure for the primary and secondary packaging of tablets. The goal is to ensure that all tablet products are packed according to quality standards, regulatory requirements, and safety protocols.

2. Scope

This SOP applies to the packaging process for all tablet products, including the primary packaging (blister packs, bottles) and secondary packaging (cartons, outer packaging).

3. Responsibilities

• Production Manager: Ensures that the packaging process is performed as per the SOP and that all equipment and materials are available and functional.
• Packaging Operator: Operates the packing machines, ensuring proper packing of tablets and verifies the accuracy of the labels and packaging materials used.
• Quality Control (QC) Inspector: Conducts quality checks during and after the packaging process, ensuring compliance with specifications and regulatory requirements.
• Maintenance Personnel: Ensures that all packaging equipment is properly maintained and calibrated to prevent malfunctions during the packing process.

4. Accountability

The Production Manager is accountable for ensuring the compliance of the primary and secondary packaging process as per this SOP. The QC department is responsible for verifying the packaging quality and addressing any issues identified during the packaging process.

5. Procedure

5.1 Preparation for Packaging

1. Ensure that all packaging materials, including labels, blister packs, cartons, and other supplies, are available and meet specifications (Annexure-1).
2. Verify that the packaging equipment is calibrated and functioning correctly. Check for any potential defects or maintenance issues (Annexure-2).
3. Set up the packaging station, ensuring it is clean, organized, and free of any contaminants (Annexure-3).
4. Review the batch production record to confirm the correct product, batch, and packaging materials are being used (Annexure-4).

5.2 Primary Packaging Process

1. Start the primary packing line (e.g., blister packaging or bottling) and ensure that the tablets are correctly inserted into the packaging format (Annexure-5).
2. Inspect each package to verify that the correct number of tablets is included and that there are no defects such as cracked or broken tablets (Annexure-6).
3. Verify that each package is sealed correctly to prevent contamination or tampering (Annexure-7).
4. Confirm that each package is correctly labeled with batch number, expiry date, and other regulatory information (Annexure-8).
5. If any issues are identified, stop the line and address the issue immediately (Annexure-9).

5.3 Secondary Packaging Process

1. Once the primary packaging is complete, proceed with the secondary packaging (e.g., carton packing, labeling, and sealing) (Annexure-10).
2. Check that each carton contains the correct number of blister packs or bottles as per the batch record (Annexure-11).
3. Ensure that each carton is correctly labeled with product details, batch number, and other required information (Annexure-12).
4. Verify that the cartons are sealed properly and are free from damage (Annexure-13).
5. Inspect the labeling and ensure that the labels on the cartons match the corresponding primary packages (Annexure-14).

5.4 Final Quality Checks

1. Perform a final inspection of the packed products to ensure all quality standards are met, including correct labeling, sealing, and packaging (Annexure-15).
2. Ensure that the finished goods are stored in the designated storage area, with proper handling to prevent damage (Annexure-16).
3. Complete the batch record, including the packing details, inspector’s notes, and any corrective actions taken during the process (Annexure-17).
4. Submit the batch for final QA approval before releasing it for distribution (Annexure-18).

5.5 Handling Defects

1. Document any defects found during the packaging process in the defect log (Annexure-19).
2. Flag any defective batches for investigation and corrective action (Annexure-20).
3. Take appropriate corrective actions, such as replacing faulty packaging materials or recalibrating equipment (Annexure-21).
4. Ensure that any defective products are properly segregated and labeled as “Rejected” (Annexure-22).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice

7. Documents

1. Packaging Material Specifications (Annexure-1)
2. Packaging Equipment Calibration Log (Annexure-2)
3. Packaging Station Setup Checklist (Annexure-3)
4. Batch Production Record (Annexure-4)
5. Primary Packaging Log (Annexure-5)
6. Primary Packaging Inspection Log (Annexure-6)
7. Packaging Sealing Verification Log (Annexure-7)
8. Labeling Inspection Log (Annexure-8)
9. Defect Log (Annexure-9)
10. Secondary Packaging Log (Annexure-10)
11. Secondary Packaging Inspection Log (Annexure-11)
12. Carton Sealing and Labeling Log (Annexure-12)
13. Final Product Inspection Log (Annexure-13)
14. Finished Goods Storage Log (Annexure-14)
15. Batch Record Completion Log (Annexure-15)
16. Corrective Action Log (Annexure-16)
17. Product Release Log (Annexure-17)
18. Defective Product Report (Annexure-18)
19. Packaging Defect Log (Annexure-19)
20. Root Cause Analysis Report (Annexure-20)
21. Segregated Product Handling Log (Annexure-21)
22. Rejected Product Log (Annexure-22)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• USP <1079> – Good Storage and Distribution Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Packaging Material Specifications

Material	Specification	Supplier
Blister Foil	Aluminum foil with PVC backing	PackTech Ltd.

Annexure-2: Packaging Equipment Calibration Log

Machine	Calibration Date	Next Calibration Due	Operator
Carton Sealing Machine	01/04/2026	01/04/2027	John Doe