Standard Operating Procedure for Strip Packing Process for Coated Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/233/2025 |
| Supersedes | SOP/TAB/233/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
The purpose of this SOP is to provide instructions for the strip packing of coated tablets, ensuring compliance with GMP standards. This SOP covers the setup, operation, and inspection of the strip packing machine, ensuring proper sealing, labeling, and packaging to maintain the quality and integrity of the tablets.
2. Scope
This SOP applies to the strip packing process for coated tablets. It covers the preparation, setup, operation, and inspection of the strip packing machine, including the use of appropriate packaging materials, sealing, and labeling of the finished product.
3. Responsibilities
- Production Manager: Oversees the strip packing process, ensuring that all operations are performed according to the SOP.
- Packing Line Operator: Operates the strip packing machine and ensures that the tablets are packed correctly with proper sealing and labeling.
- QA Personnel: Verifies the quality of the packed products, performs inspections, and ensures compliance with packaging specifications.
- Maintenance Personnel: Ensures that the packing machine is properly maintained, calibrated, and in good working condition.
4. Accountability
The Production Manager is responsible for ensuring the strip packing process is carried out in compliance with this SOP. The QA department is responsible for monitoring the quality and integrity of the packed tablets and ensuring proper documentation is maintained.
5. Procedure
5.1 Strip Packing Setup
- Ensure all required packing materials (strip foil, backing material, labels) are available and meet the required specifications (Annexure-1).
- Check that the strip packing machine is clean and calibrated, and verify that the settings are correct for the batch being processed (Annexure-2).
- Ensure that the correct batch of coated tablets is available and the batch record is reviewed (Annexure-3).
- Perform a dry run of the strip packing machine to verify the correct operation of the sealing and labeling components (Annexure-4).
5.2 Loading of Tablets
- Verify the number of tablets being loaded onto the packing machine, ensuring the correct number of tablets per strip (Annexure-5).
- Ensure that the tablets are placed in the packing machine’s feeding system without any defects or breakages (Annexure-6).
- Check that the feeding mechanism functions properly, with a consistent flow of tablets onto the strip packing machine (Annexure-7).
5.3 Sealing and Labeling
- Ensure the correct strip foil and backing material are used for sealing (Annexure-8).
- Set the temperature and pressure parameters on the sealing machine as per specifications (Annexure-9).
- Initiate the sealing process and verify the seal integrity by performing a visual inspection (Annexure-10).
- Ensure that the labeling process is accurate, with all necessary information (e.g., product name, batch number, expiration date) on the label (Annexure-11).
5.4 Quality Control and Inspection
- Perform in-process checks to verify the correct number of tablets in each strip, and inspect the integrity of the seal (Annexure-12).
- Inspect the packed strips for labeling accuracy, alignment, and legibility (Annexure-13).
- Perform a final quality check before the product is released for storage (Annexure-14).
5.5 End-of-Line Activities
- After the packing run, ensure that all finished products are stored in the appropriate storage area and are labeled for traceability (Annexure-15).
- Record all packaging material usage and dispose of any unused or damaged materials (Annexure-16).
- Ensure that all batch production records are completed and signed off by QA (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
7. Documents
- Strip Packing Material Specifications (Annexure-1)
- Cleaning and Calibration Checklist (Annexure-2)
- Batch Record and Product Specifications (Annexure-3)
- Strip 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: Strip Packing Material Specifications
| Material | Specification | Supplier |
|---|---|---|
| Strip Foil | Aluminum foil with PVC backing | PackTech Ltd. |
Annexure-2: Cleaning and Calibration Checklist
| Equipment | Calibration/Cleaning Date | Responsible Person |
|---|---|---|
| Strip Packing Machine | 01/04/2026 | John Doe |
Annexure-3: Batch Record and Product Specifications
| Batch Number | Tablet Type | Specification |
|---|---|---|
| Batch 12345 | Coated Tablets | Weight: 500 mg |
Annexure-4: Strip Packing Machine Dry Run Records
| Date | Machine Model | Operator | Dry Run Results |
|---|---|---|---|
| 01/04/2026 | Model X-300 | John Doe | No issues, machine functioning correctly |