Standard Operating Procedure for Cartoning Capsules for Distribution
| Department | Capsule Packaging |
|---|---|
| SOP No. | SOP/CP/209/2025 |
| Supersedes | SOP/CP/209/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to define the process for cartoning capsules for distribution. It ensures the capsules are securely packed in cartons, appropriately labeled, and ready for transportation in compliance with regulatory and GMP standards.
2. Scope
This SOP applies to the process of cartoning capsules for distribution, including the proper handling of capsules, the use of packaging materials, and the final inspection before shipment.
3. Responsibilities
- Packaging Operator: Responsible for placing the sealed primary packages of capsules into cartons, ensuring that the correct number of capsules per carton is maintained and all packaging steps are followed properly.
- Quality Control (QC) Team: Ensures that the cartoning process meets quality standards, including checking that the capsules are properly packed, cartons are sealed, and labels are correct.
- Production Supervisor: Oversees the cartoning operation, ensuring that the packaging process complies with the SOP, and handles any issues or deviations during the process.
4. Accountability
The Production Manager is accountable for ensuring the proper execution of the cartoning process. The QC Manager ensures that the packaging meets quality standards and compliance with regulatory requirements.
5. Procedure
5.1 Pre-Cartoning Preparation
Before starting the cartoning process, ensure the following:
-
Verify Packaging Materials
- Ensure that all cartons, labels, and other secondary packaging materials are available and meet the required specifications.
- Check that the cartons are the correct size and are free from defects, including tears or damage that could affect product integrity.
-
Check Capsule Batch
- Confirm that the correct batch of capsules has been prepared and verified, ensuring that the batch number, quantity, and product details match the Batch Production Record (BPR).
-
Prepare Cartoning Line
- Ensure that the cartoning machine is set up and adjusted correctly for the required carton size, speed, and seal integrity.
- Confirm that the primary packaged capsules (bottles or blister packs) are available and ready for cartoning.
5.2 Cartoning Process
Follow these steps during the cartoning process:
-
Load Capsules into Cartoning Machine
- Load the sealed bottles or blister packs containing capsules onto the cartoning machine.
- Ensure the capsules are oriented properly to ensure easy loading into the cartons.
-
Pack Capsules into Cartons
- The cartoning machine should insert the sealed bottles or blister packs into cartons according to the specified quantity per carton as per the batch production record (BPR).
- Ensure that the cartons are not overfilled or underfilled and are sealed properly.
-
Seal Cartons
- Ensure that the cartons are properly sealed using the cartoning machine to prevent any contamination or tampering during transit.
-
Apply Labels to Cartons
- Ensure that each carton is labeled correctly with essential product details, including product name, batch number, manufacturing date, expiry date, and any regulatory markings.
5.3 Post-Cartoning Activities
After completing the cartoning process, ensure the following:
-
Final Inspection
- Perform a final inspection to ensure that all cartons are properly packed, sealed, and labeled.
- Ensure that the labels are legible and properly affixed to each carton.
-
Store Packaged Capsules
- Store the packed cartons in a suitable storage area, ensuring that they are protected from moisture, heat, and contamination.
- Maintain proper organization to prevent any damage or mix-up of the products.
-
Record Cartoning Data
- Document the cartoning process, including the number of cartons packed, any defects found, and the results of the final inspection.
- Ensure that records are stored in compliance with GMP and regulatory standards.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- BPR: Batch Production Record
- USP: United States Pharmacopeia
7. Documents
- Annexure 1: Cartoning Log
- Annexure 2: QC Inspection Report
- Annexure 3: Equipment Calibration Log
8. References
- USP <701> – Disintegration of Tablets and Capsules
- European Pharmacopoeia 2.9.1 – Dissolution Testing
- Good Manufacturing Practice (GMP) Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure 1: Cartoning Log
| Batch ID | Cartoning Date | Number of Cartons Packaged | Operator | Comments |
|---|---|---|---|---|
| Batch 021 | 07/02/2025 | 20,000 | John Doe | No issues |
Annexure 2: QC Inspection Report
| Batch ID | Inspection Date | Defects Identified | Corrective Actions | Final Outcome |
|---|---|---|---|---|
| Batch 021 | 07/02/2025 | None | None | Approved |
Annexure 3: Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Cartoning Machine 701 | 01/02/2025 | Jane Smith | Calibration of speed and sealing pressure | 01/02/2026 |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for cartoning capsules | QA Head |
| 01/02/2025 | 2.0 | Updated cartoning machine setup and inspection details | Improvement in quality and packaging efficiency | QA Head |