Procedure

5.1 Pre-Labeling Preparation

Before starting the labeling process, ensure the following:

1. Verify Labeling Materials
   1. 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.
2. Check the Labeling Machine Setup
   1. 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.
3. Confirm Product Details
   1. 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:

1. Load Bottles onto the Labeling Line
   1. Place the bottles onto the labeling machine conveyor. Ensure that the bottles are correctly oriented and positioned for proper labeling.
2. Apply Labels
   1. 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.
3. Ensure Accurate Label Placement
   1. Ensure the label is properly aligned, with no misplacement or incorrect orientation on the bottle. Monitor the alignment during the labeling process.
4. Label Inspection
   1. 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:

1. Final Inspection
   1. 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.
2. Correct Labeling Errors
   1. Any incorrectly labeled bottles should be removed from the line and set aside for re-labeling or disposal. Document any rework activities.
3. Store Labeled Bottles
   1. Store the labeled bottles in the appropriate storage area, ensuring they are kept under suitable environmental conditions until they are ready for distribution.
4. Record Labeling Data
   1. 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

1. Annexure 1: Labeling Log
2. Annexure 2: QC Inspection Report
3. 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