Standard Operating Procedure for Labeling Bottled Capsules
| Department | Capsule Packaging |
|---|---|
| SOP No. | SOP/CP/203/2025 |
| Supersedes | SOP/CP/203/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This SOP outlines the procedure for labeling bottled capsules to ensure that all capsules are correctly labeled with necessary product information and in compliance with regulatory standards.
2. Scope
This SOP applies to the labeling of all bottled capsules within the packaging process. It covers the labeling machine setup, label application, and verification procedures to ensure proper labeling of products.
3. Responsibilities
- Labeling Operator: Responsible for applying labels to bottles, ensuring correct label placement, and monitoring the machine during the labeling process.
- Quality Control (QC) Team: Responsible for inspecting the labeled bottles and ensuring that labels are accurate, properly placed, and free from defects.
- Production Supervisor: Ensures the labeling process is performed as per the SOP and monitors operator performance during the process.
4. Accountability
The Production Manager is accountable for the correct implementation of the labeling process in accordance with this SOP. The QC Manager ensures the quality of the labeling output.
5. Procedure
5.1 Pre-Labeling Preparation
Before starting the labeling process, ensure the following:
-
Verify Labeling Materials
- Ensure that all labels, bottles, and any additional packaging materials are available and in good condition. Verify label stock to ensure it matches the product specifications.
-
Check the Labeling Machine Setup
- Ensure that the labeling machine is properly set up to handle the bottle size and label type. Verify that all machine parts are clean and functioning correctly.
-
Confirm Product Details
- Confirm that the correct batch of capsules is ready for labeling. Verify the batch number, product details, and expiration dates to ensure consistency with labeling requirements.
5.2 Labeling Process
Follow these steps for the labeling procedure:
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Load Bottles onto the Labeling Line
- Place the bottles onto the labeling machine conveyor. Ensure that the bottles are correctly oriented and positioned for proper labeling.
-
Apply Labels
- Start the labeling machine and ensure that labels are applied correctly to each bottle. The label should cover the required areas such as the front and side of the bottle, and it should be free from wrinkles or air bubbles.
-
Ensure Accurate Label Placement
- Ensure the label is properly aligned, with no misplacement or incorrect orientation on the bottle. Monitor the alignment during the labeling process.
-
Label Inspection
- Perform visual inspections of a sample of labeled bottles to ensure the label is clear, legible, and free of defects. Check for any missing or incorrect information on the label (e.g., product name, batch number, expiration date).
5.3 Post-Labeling Activities
After labeling, ensure the following:
-
Final Inspection
- Perform a final inspection of the labeled bottles to confirm that all bottles have the correct label applied. Ensure that labels are clean, without defects, and aligned properly.
-
Correct Labeling Errors
- Any incorrectly labeled bottles should be removed from the line and set aside for re-labeling or disposal. Document any rework activities.
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Store Labeled Bottles
- Store the labeled bottles in the appropriate storage area, ensuring they are kept under suitable environmental conditions until they are ready for distribution.
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Record Labeling Data
- Document all relevant labeling details, including the number of bottles labeled, any defects found, and the results of the final inspection. Store records in compliance with GMP standards.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- EP: European Pharmacopoeia
- USP: United States Pharmacopeia
7. Documents
- Annexure 1: Labeling 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: Labeling Log
| Batch ID | Labeling Date | Number of Bottles | Operator | Comments |
|---|---|---|---|---|
| Batch 015 | 03/02/2025 | 50,000 | John Doe | No defects |
Annexure 2: QC Inspection Report
| Batch ID | Inspection Date | Defects Identified | Corrective Actions | Final Outcome |
|---|---|---|---|---|
| Batch 015 | 03/02/2025 | None | None | Approved |
Annexure 3: Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Labeling Machine 601 | 01/02/2025 | Jane Smith | Calibration of labeling speed and accuracy | 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 labeling process | QA Head |
| 01/02/2025 | 2.0 | Updated machine setup and inspection process | Improvement of labeling accuracy | QA Head |