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
- Production Manager: Oversees the packing process and ensures that all operations are performed according to the SOP.
- Packing Line Operator: Operates the blister packing machine, monitors the packing process, and ensures all tablets are packed as per the specifications.
- QA Personnel: Reviews and approves the packing process, inspects packaging materials, and verifies final product quality.
- Maintenance Personnel: Ensures that the blister packing machine is maintained, calibrated, and in good working condition.
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
- Ensure that the appropriate blister pack materials are available, including PVC/PVDC blister sheets, aluminum foil, and any additional components (Annexure-1).
- 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).
- Verify that the correct tablet type is used for packing, and the batch records are reviewed for consistency (Annexure-3).
- Perform a dry run of the blister packing machine to ensure it is functioning correctly, and record the results (Annexure-4).
5.2 Loading of Tablets
- Ensure that the tablets are correctly aligned and placed in the blister cavities of the blister pack (Annexure-5).
- Confirm that the correct batch of tablets is used, and cross-check the batch number with the batch record (Annexure-6).
- 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
- Once the tablets are correctly loaded, initiate the sealing process using the correct sealing conditions (temperature, pressure, and time) (Annexure-8).
- Ensure that the foil seal is intact and that the blister pack is securely sealed to prevent contamination (Annexure-9).
- 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
- Perform in-process checks to verify that the blister packs meet all specifications, including sealing integrity, tablet count, and labeling accuracy (Annexure-11).
- Inspect each blister pack for defects such as broken seals, missing labels, or damaged packaging (Annexure-12).
- Complete the packaging log and ensure that all checks and inspections are properly documented (Annexure-13).
5.5 End-of-Line Activities
- After the packing run, inspect and store the finished blister packs in the appropriate storage area, following all storage conditions (Annexure-14).
- Ensure that any unused blister packaging materials are securely stored and labeled for future use (Annexure-15).
- Ensure that batch records are signed off by the QA department, and the final product is approved for release (Annexure-16).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
7. Documents
- Blister Pack Material Specifications (Annexure-1)
- Cleaning and Calibration Checklist (Annexure-2)
- Batch Record and Product Specifications (Annexure-3)
- Blister Packing Machine Dry Run Records (Annexure-4)
- Tablet Loading Verification Log (Annexure-5)
- Tablet Feeder Functionality Log (Annexure-6)
- Sealing and Labeling Parameters (Annexure-7)
- Sealing Quality Check Log (Annexure-8)
- Labeling Verification and Inspection Log (Annexure-9)
- In-Process Packaging Inspection Log (Annexure-10)
- Finished Product Inspection Log (Annexure-11)
- Packaging Log and Documentation (Annexure-12)
- Finished Product Storage Log (Annexure-13)
- Packaging Material Storage Log (Annexure-14)
- Batch Record and QA Approval Log (Annexure-15)
- Packaging Process and Inspection Records (Annexure-16)
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: 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
You said: |
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 |