Standard Operating Procedure for Tablet Packing Line Setup and Operation
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/231/2025 |
| Supersedes | SOP/TAB/231/2022 |
| Page No. | Page 1 of 5 |
| 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 clear instructions for setting up and operating the tablet packing line in compliance with GMP guidelines. This ensures that the packing process is performed accurately, efficiently, and in a controlled environment to meet quality standards.
2. Scope
This SOP applies to all packing lines used for tablet packaging, including blister packaging, strip packaging, and bottle packing. It covers the setup, operation, and routine maintenance of these systems, including the use of materials, equipment calibration, and packaging inspections.
3. Responsibilities
- Production Manager: Ensures proper setup, operation, and adherence to SOP during the packing process.
- Packing Line Operator: Responsible for operating the packing line, ensuring correct setup, and maintaining equipment during production runs.
- QA Personnel: Monitors the packaging process to ensure it meets quality standards, performs in-process checks, and signs off on the final batch records.
- Maintenance Personnel: Ensures that the packing line equipment is maintained and calibrated as per SOP.
4. Accountability
The Production Manager is accountable for ensuring the packing line is set up, operated, and maintained according to this SOP. The QA department is accountable for overseeing the packing process, conducting audits, and ensuring product quality standards are met.
5. Procedure
5.1 Packing Line Setup
- Verify that all required packing materials (blister packs, bottles, labels, etc.) are available and meet the required specifications (Annexure-1).
- Check that all equipment involved in the packing process is clean and free of any contaminants (Annexure-2).
- Calibrate the packing line equipment, including the filling machine, label applicator, and sealing machine, to ensure accurate performance (Annexure-3).
- Ensure that the packing line is set up according to the specific product being packed, ensuring correct bottle sizes, blister packs, or other packaging materials are used (Annexure-4).
- Perform a dry run of the packing line to verify that the equipment is functioning properly (Annexure-5).
5.2 Operation of Packing Line
- Load the tablets onto the packing line feeder, ensuring the correct number and type of tablets are placed on the line (Annexure-6).
- Start the packing line, monitor the tablet filling, labeling, and sealing processes to ensure accurate and efficient packing (Annexure-7).
- During the process, verify that the packaging materials match the batch production records (Annexure-8).
- Perform in-process checks for weight uniformity, label accuracy, and proper sealing (Annexure-9).
- Conduct visual inspections of the packed tablets to identify any defects such as broken seals, missing labels, or damaged packaging (Annexure-10).
5.3 Packaging Line Maintenance
- Ensure that the packing line is properly maintained according to the schedule outlined in the maintenance log (Annexure-11).
- Calibrate the equipment regularly to ensure accurate operation and prevent errors (Annexure-12).
- Immediately report any equipment malfunction or breakdown to the maintenance team for repair (Annexure-13).
5.4 End-of-Line Activities
- After the packing run, ensure all packaged tablets are stored in the appropriate storage area (Annexure-14).
- Seal and label any remaining packaging materials and store them for future use (Annexure-15).
- Ensure that the batch production records are completed accurately and signed off by the QA department (Annexure-16).
- Ensure that a final inspection of the packed product is done before shipment (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
7. Documents
- Packing Material Specifications (Annexure-1)
- Cleaning and Calibration Checklist (Annexure-2)
- Equipment Calibration Records (Annexure-3)
- Packaging Setup Checklist (Annexure-4)
- Packing Line Dry Run Records (Annexure-5)
- Tablet Feed Verification Log (Annexure-6)
- Packing Process Monitoring Log (Annexure-7)
- Batch Record and Packaging Materials Matching Report (Annexure-8)
- In-Process Packaging Inspection Log (Annexure-9)
- Final Product Inspection Log (Annexure-10)
- Maintenance Schedule and Records (Annexure-11)
- Calibration Log (Annexure-12)
- Equipment Malfunction and Repair Report (Annexure-13)
- Final Product Storage and Shipping Log (Annexure-14)
- Packaging Material Storage Log (Annexure-15)
- Batch Production and QA Approval Log (Annexure-16)
- Shipment Inspection Log (Annexure-17)
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: Packing Material Specifications
| Material | Specification | Supplier |
|---|---|---|
| Blister Pack | Clear, tamper-proof, PVC | PackTech Inc. |
Annexure-2: Cleaning and Calibration Checklist
| Equipment | Calibration/Cleaning Date | Person Responsible |
|---|---|---|
| Tablet Filler | 01/04/2026 | John Doe |
Annexure-3: Equipment Calibration Records
| Equipment | Calibration Date | Calibration Validity |
|---|---|---|
| Tablet Filler | 01/04/2026 | 01/04/2027 |
Annexure-4: Packaging Setup Checklist
| Step | Action | Status |
|---|---|---|
| 1 | Verify tablet type and packing material | Completed |