SOP Guide for Pharma

Tablets: SOP for Blister Packing of Immediate Release Tablets – V 2.0

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Tablets: SOP for Blister Packing of Immediate Release Tablets – V 2.0

Standard Operating Procedure for Blister Packing of Immediate Release Tablets

Department Tablet
SOP No. SOP/TAB/232/2025
Supersedes SOP/TAB/232/2022
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 provides the procedure for blister packing of immediate release tablets to ensure consistent and reliable packaging of the tablets in accordance with GMP standards. The goal is to ensure proper sealing, labeling, and packaging to maintain the integrity and quality of the tablets.

2. Scope

This SOP applies to all blister packing processes for immediate release tablets. It covers the preparation, setup, operation, and inspection of the blister packing machine, including the use of blister packs, sealing, labeling, and inspection procedures.

3. Responsibilities

4. Accountability

The Production Manager is responsible for ensuring that the blister packing process is set up, operated, and maintained in accordance with this SOP. The QA department is accountable for verifying product quality and packaging integrity.

5. Procedure

5.1 Blister Packing Setup

  1. Ensure that the appropriate blister pack materials are available, including PVC/PVDC blister sheets, aluminum foil, and any additional components (Annexure-1).
  2. Check the equipment for cleanliness and readiness. Ensure that the blister packing machine is calibrated and set up according to the specifications for the batch being packed (Annexure-2).
  3. Verify that the correct tablet type is used for packing, and the batch records are reviewed for consistency (Annexure-3).
  4. Perform a dry run of the blister packing machine to ensure it is functioning correctly, and record the results (Annexure-4).
See also  Tablets: SOP for Blend Homogeneity Check During Granulation - V 2.0

5.2 Loading of Tablets

  1. Ensure that the tablets are correctly aligned and placed in the blister cavities of the blister pack (Annexure-5).
  2. Confirm that the correct batch of tablets is used, and cross-check the batch number with the batch record (Annexure-6).
  3. Verify that the blister packing machine feeder is functioning properly and feeding tablets into the blister cavities without any issues (Annexure-7).

5.3 Sealing and Labeling

  1. Once the tablets are correctly loaded, initiate the sealing process using the correct sealing conditions (temperature, pressure, and time) (Annexure-8).
  2. Ensure that the foil seal is intact and that the blister pack is securely sealed to prevent contamination (Annexure-9).
  3. Attach the correct label to each blister pack, ensuring that all required information, such as product name, batch number, expiration date, and manufacturing details, are clearly printed (Annexure-10).

5.4 Quality Control and Inspection

  1. Perform in-process checks to verify that the blister packs meet all specifications, including sealing integrity, tablet count, and labeling accuracy (Annexure-11).
  2. Inspect each blister pack for defects such as broken seals, missing labels, or damaged packaging (Annexure-12).
  3. Complete the packaging log and ensure that all checks and inspections are properly documented (Annexure-13).

5.5 End-of-Line Activities

  1. After the packing run, inspect and store the finished blister packs in the appropriate storage area, following all storage conditions (Annexure-14).
  2. Ensure that any unused blister packaging materials are securely stored and labeled for future use (Annexure-15).
  3. Ensure that batch records are signed off by the QA department, and the final product is approved for release (Annexure-16).
See also  Tablets: SOP for Tablet Drying Process - V 2.0

6. Abbreviations

7. Documents

  1. Blister Pack Material Specifications (Annexure-1)
  2. Cleaning and Calibration Checklist (Annexure-2)
  3. Batch Record and Product Specifications (Annexure-3)
  4. Blister Packing Machine Dry Run Records (Annexure-4)
  5. Tablet Loading Verification Log (Annexure-5)
  6. Tablet Feeder Functionality Log (Annexure-6)
  7. Sealing and Labeling Parameters (Annexure-7)
  8. Sealing Quality Check Log (Annexure-8)
  9. Labeling Verification and Inspection Log (Annexure-9)
  10. In-Process Packaging Inspection Log (Annexure-10)
  11. Finished Product Inspection Log (Annexure-11)
  12. Packaging Log and Documentation (Annexure-12)
  13. Finished Product Storage Log (Annexure-13)
  14. Packaging Material Storage Log (Annexure-14)
  15. Batch Record and QA Approval Log (Annexure-15)
  16. Packaging Process and Inspection Records (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: Blister Pack Material Specifications

Material Specification Supplier
Blister Pack Clear PVC with foil back PackTech Ltd.

Annexure-2: Cleaning and Calibration Checklist

Equipment Calibration/Cleaning Date Responsible Person
Blister Packing Machine 01/04/2026 Jane Smith

Annexure-3: Batch Record and Product Specifications

Batch Number Tablet Type Specification
Batch 12345 Immediate Release Weight 500 mg

Annexure-4: Blister Packing Machine Dry Run Records

Date Machine Model

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Operator Dry Run Results
01/04/2026 Model X-200 John Doe No issues, machine functions correctly

Annexure-5: Tablet Loading Verification Log

Batch Number Tablets Loaded (Quantity) Loaded By Verification Status
Batch 12345 5000 tablets John Doe Verified

Annexure-6: Tablet Feeder Functionality Log

Time Feeder Status Operator Comments
09:00 AM Normal Jane Smith No issues, tablets loaded smoothly

Annexure-7: Sealing and Labeling Parameters

Parameter Setting Measured Value Operator
Sealing Temperature 180°C 180°C John Doe
Labeling Speed 50 units/min 50 units/min Jane Smith

Annexure-8: Sealing Quality Check Log

Time Seal Integrity Test Operator Result
09:30 AM Visual Inspection John Doe Pass

Annexure-9: Labeling Verification and Inspection Log

Time Labeling Check Operator Result
09:45 AM Label alignment and printing Jane Smith Pass

Annexure-10: In-Process Packaging Inspection Log

Inspection Item Inspection Date Inspector Inspection Result Action Taken
Seal Integrity 01/04/2026 John Doe Pass —

Annexure-11: Finished Product Inspection Log

Inspection Item Inspection Date Inspector Result Comments
Blister Pack Integrity 01/04/2026 Jane Smith Pass —

Annexure-12: Packaging Log and Documentation

Batch Number Number of Units Packed Packing Date Operator
Batch 12345 5000 units 01/04/2026 John Doe

Annexure-13: Finished Product Storage Log

Batch Number Storage Location Quantity Stored Storage Date
Batch 12345 Warehouse A 5000 units 01/04/2026

Annexure-14: Packaging Material Storage Log

Material Storage Location Quantity Stored Last Inventory Date
Blister Pack Material Warehouse A 1000 units 02/04/2026

Annexure-15: Batch Record and QA Approval Log

Batch Number QA Review Date Batch Released Signature
Batch 12345 01/04/2026 Yes QA Manager

Annexure-16: Packaging Process and Inspection Records

Batch Number Inspection Date Inspection Result Corrective Action
Batch 12345 01/04/2026 Pass —

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP creation New process QA Head
01/02/2025 2.0 Updated packing and inspection procedures Process optimization and equipment upgrades QA Head
See also  Tablets: SOP for Disintegration Testing for Immediate Release Tablets - V 2.0
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