Standard Operating Procedure for Cartoning and Final Packaging of Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/244/2025 |
| Supersedes | SOP/TAB/244/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to ensure that the final packaging and cartoning of tablets is performed accurately and efficiently. This includes ensuring that the product is correctly packed, labeled, and ready for shipping in compliance with Good Manufacturing Practices (GMP) and regulatory standards.
2. Scope
This SOP applies to the final cartoning and packaging operations for all tablet products, including primary packaging, labeling, and carton sealing. It covers the steps involved in preparing, inspecting, and packaging tablets into cartons for distribution and sale.
3. Responsibilities
- Packaging Operators: Responsible for performing the cartoning and final packaging operations, ensuring accuracy in packaging, labeling, and carton sealing.
- Quality Control (QC) Inspectors: Responsible for inspecting the final packaging and ensuring that all packaging materials and labeling are correct before release.
- Production Manager: Ensures compliance with SOPs, oversees the cartoning process, and addresses any discrepancies or deviations during packaging.
- Warehouse Manager: Manages the storage and handling of finished products and ensures proper inventory control after packaging.
4. Accountability
The Production Manager is accountable for ensuring that all packaging operations are conducted in accordance with this SOP. The QC team is responsible for verifying the final packaging before release.
5. Procedure
5.1 Preparation for Cartoning
- Ensure that all required packaging materials, including cartons, labels, inserts, and shrink wraps, are available and correctly stored (Annexure-1).
- Verify that the batch details (e.g., batch number, expiry date) and other required information are printed on the labels (Annexure-2).
- Check that all necessary documents, including packaging records and quality assurance approval, are in place before initiating the packaging process (Annexure-3).
5.2 Cartoning Process
- Ensure that the correct product is being packed into the correct carton. Each carton must match the product specifications and labeling (Annexure-4).
- Load the product into the cartons according to the predetermined packing configuration, ensuring that tablets are arranged in the correct orientation and quantity (Annexure-5).
- Ensure the packaging line is clean and free of any debris to prevent contamination during cartoning (Annexure-6).
- Each carton must be sealed properly to prevent tampering. Verify that each carton is securely sealed and labeled (Annexure-7).
5.3 Quality Control Inspection
- QC personnel must inspect a representative sample of cartons at regular intervals during the cartoning process to ensure the correctness of packaging and labeling (Annexure-8).
- If any discrepancies are found, stop the packing process immediately, investigate the cause, and rectify the issue before resuming (Annexure-9).
- Ensure that each carton is properly labeled with the required regulatory and product information (Annexure-10).
5.4 Final Packaging and Carton Sealing
- Once the cartons are filled and inspected, close the cartons securely using approved sealing methods (Annexure-11).
- Ensure that the final product is stored in a secure and clean environment, ready for shipment (Annexure-12).
- Document all activities performed during the cartoning process, including any deviations or corrective actions (Annexure-13).
5.5 Documentation and Record-Keeping
- Ensure that all relevant documentation, such as packaging logs and inspection records, are completed accurately and in a timely manner (Annexure-14).
- All records must be retained for the required duration according to company policies and regulatory requirements (Annexure-15).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FIFO: First In, First Out
7. Documents
- Packaging Material Verification Log (Annexure-1)
- Labeling Verification Log (Annexure-2)
- Packaging Approval Records (Annexure-3)
- Carton Filling Log (Annexure-4)
- Product Inspection Log (Annexure-5)
- Packaging Line Cleanliness Log (Annexure-6)
- Carton Sealing Inspection Log (Annexure-7)
- QC Carton Inspection Log (Annexure-8)
- Corrective Action Log (Annexure-9)
- Labeling Inspection Log (Annexure-10)
- Final Packaging Log (Annexure-11)
- Finished Product Storage Log (Annexure-12)
- Packaging Process Documentation Log (Annexure-13)
- Packaging Record Retention Log (Annexure-14)
- Documentation Retention Log (Annexure-15)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
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 Verification Log
| Material | Verification Date | Operator | Verification Status |
|---|---|---|---|
| Cartons | 01/07/2026 | Jane Smith | Verified |
Annexure-2: Labeling Verification Log
| Label | Verification Date | Inspector | Verification Status |
|---|---|---|---|
| Blister Pack | 01/07/2026 | John Doe | Verified |
Annexure-3: Packaging Approval Records
| Batch Number | Approval Date | Approver | Approval Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Approved |
Annexure-4: Carton Filling Log
| Batch Number | Carton Type | Filling Date | Operator | Quantity Filled | Carton Sealing Status |
|---|---|---|---|---|---|
| Batch 12345 | Standard Carton | 01/07/2026 | John Doe | 1000 | Sealed |
Annexure-5: Product Inspection Log
| Product | Inspection Date | Inspector | Inspection Result | Comments |
|---|---|---|---|---|
| Blister Pack | 02/07/2026 | Jane Smith | Pass | No issues found |
| Blister Pack | 02/07/2026 | John Doe | Pass | Uniform weight observed |
Annexure-6: Packaging Line Cleanliness Log
| Area | Cleaning Date | Operator | Cleaning Status |
|---|---|---|---|
| Carton Filling Station | 01/07/2026 | John Doe | Cleaned and sanitized |
| Carton Sealing Station | 01/07/2026 | Jane Smith | Cleaned and sanitized |
Annexure-7: Carton Sealing Inspection Log
| Batch Number | Sealing Date | Inspector | Sealing Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Sealed |
Annexure-8: QC Carton Inspection Log
| Batch Number | Inspection Date | Inspector | Inspection Result | Comments |
|---|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Pass | All packaging details match the specification |
Annexure-9: Corrective Action Log
| Issue | Corrective Action Date | Corrective Action Taken | Responsible Person |
|---|---|---|---|
| Incorrect Labeling | 02/07/2026 | Corrected label and resealed cartons | John Doe |
Annexure-10: Labeling Inspection Log
| Batch Number | Labeling Date | Inspector | Inspection Result | Comments |
|---|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Pass | Label content matches product specifications |
Annexure-11: Final Packaging Log
| Batch Number | Packaging Date | Operator | Packaging Status |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Completed |
Annexure-12: Finished Product Storage Log
| Material | Storage Date | Storage Location | Quantity Stored |
|---|---|---|---|
| Blister Pack | 02/07/2026 | Storage A, Shelf 5 | 50,000 units |
Annexure-13: Packaging Process Documentation Log
| Document Type | Document Reference Number | Document Date |
|---|---|---|
| Packaging Record | PKG-12345 | 01/07/2026 |
Annexure-14: Packaging Record Retention Log
| Document Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Packaging Log | 5 years | Jane Smith | Storage B, Shelf 2 |
Annexure-15: Documentation Retention Log
| Document Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Final Packaging Records | 5 years | Jane Smith | Storage A, Shelf 3 |
16. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/07/2025 | 2.0 | Updated packaging procedures | Process optimization | QA Head |