standards.

4. Accountability

The Production Manager is accountable for ensuring that labeling inspections are performed as part of the packing process. The QC Manager is responsible for verifying the accuracy and correctness of labels, while the QA Manager is responsible for ensuring compliance with all regulations and documentation requirements.

5. Procedure

5.1 Pre-Production Setup

1. Ensure that all labeling materials, including labels, printers, and adhesive equipment, are in good working condition before the start of production.
2. Verify that the correct labels are available for the product being packed, ensuring that they match the specifications provided in the Batch Manufacturing Record (BMR).
3. Ensure that all operators are trained and familiar with the labeling requirements, including regulatory compliance standards and product-specific labeling guidelines.
4. Perform a trial run of the labeling machine to ensure that it is correctly applying labels at the required positions and in the correct orientation.

5.2 Inline Labeling Inspection

1. During the packing process, monitor the inline labeling system to ensure that labels are applied correctly and consistently. The label should be placed in the designated location on the product and adhere properly without wrinkles or misalignment.
2. Inspect the labels for legibility, ensuring that all required information (e.g., product name, batch number, expiry date, and regulatory information) is printed clearly and without errors.
3. Perform random checks on labeled products at specified intervals (e.g., every 100th unit or as per the BMR) to verify label placement, content accuracy, and overall quality.
4. If discrepancies are found, stop the production line immediately and investigate the root cause of the issue (e.g., incorrect label, misalignment, printer malfunction). Address the issue before resuming production.

5.3 Handling Deviations

1. If a labeling issue is detected, such as incorrect labeling, missing information, or misalignment, take the following corrective actions:
• Stop the packing process and remove the defective products from the production line.
• Identify the cause of the deviation (e.g., labeling machine malfunction, incorrect labels used) and correct the issue.
• Verify that the labeling equipment is functioning correctly, recalibrate or reset it if necessary, and restart the production process.
• Document all deviations and corrective actions in the Deviation Report (Annexure-1), and ensure that the report is reviewed and signed by the QA team.

5.4 Post-Production Activities

1. Once the packing process is complete, review the batch production records and ensure that the labeling inspection process has been documented correctly.
2. Ensure that all labeled products meet the required specifications and are ready for distribution or storage.
3. Ensure that any defective products identified during the inline inspection process are segregated and either reworked or disposed of according to company procedures.

5.5 Documentation and Record-Keeping

1. Document all inline labeling inspections in the Inline Labeling Inspection Log (Annexure-2), ensuring that each entry includes the batch number, time, inspector name, label details, and any discrepancies noted.
2. Ensure that all deviations and corrective actions are documented in the Deviation Report (Annexure-1). This report must include the issue description, corrective action taken, and personnel involved in resolving the issue.
3. Review all records for completeness and accuracy before submitting them for final approval by the QA team. Store all records for a minimum of two years or as required by regulatory guidelines.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Inline Labeling Inspection Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Labeling Requirements in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Incorrect label applied	Replaced with correct label	John Doe

Annexure-2: Inline Labeling Inspection Log

Batch Number	Time	Inspector	Label Details	Remarks
12345	09:00 AM	Jane Smith	Label A	Within specification
12345	09:30 AM	Michael Lee	Label B	Misalignment detected, corrective action taken

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head