Standard Operating Procedure for Labeling Verification in Tablet Packaging

Department	Tablet
SOP No.	SOP/TAB/193/2025
Supersedes	SOP/TAB/193/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish procedures for verifying the accuracy and compliance of labels used in tablet packaging, ensuring that they meet regulatory requirements and accurately represent the product inside the packaging.

2. Scope

This SOP applies to all tablet packaging operations within the facility. It covers the process of label verification during packaging to ensure that product labels are accurate, legible, and in compliance with applicable regulatory standards.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the label verification process, reviewing label content, and ensuring compliance with regulatory requirements.
• Packaging Team: Responsible for ensuring that the correct label is applied to the correct product packaging and verifying that all labeling information is accurate.
• Regulatory Affairs: Responsible for ensuring that the labels comply with all applicable regulatory guidelines, such as FDA, EMA, or local regulatory requirements.

4. Accountability

The QA Manager is accountable for ensuring the correct implementation of this SOP and the accuracy of labeling. The Packaging Manager is responsible for ensuring that all packaging operations follow this SOP during the production process.

5. Procedure

5.1 Label Preparation

1. Ensure that all labels are prepared and approved according to the approved packaging artwork and specifications.
2. All label content, including product name, strength, batch number, expiry date, and other regulatory information, must be checked for accuracy before printing (Annexure-1).
3. Verify that the label design is in compliance with regulatory guidelines and company standards.

5.2 Label Verification Process

1. Before the start of packaging, the packaging supervisor must verify that the correct labels are available for the specific tablet product being packaged.
2. For each batch, perform a first-off check to ensure that the label applied to the packaging matches the approved label for the corresponding product.
3. Verify that the label information matches the product batch details, including the batch number, expiry date, and product specifications. This includes verifying that the label is legible and printed correctly (Annexure-2).
4. Verify that the label is applied to the correct packaging component, whether it be bottles, blisters, or cartons, to avoid mix-ups between products.

5.3 Label Application

1. Ensure that the correct label is applied to each packaging unit in accordance with the product’s specifications.
2. Perform a secondary check during the packaging process to ensure that labels are being applied correctly. Any discrepancy should be flagged immediately, and corrective actions should be taken.

5.4 Documentation and Records

1. Document the label verification process, including the batch number, packaging date, and any discrepancies found during verification (Annexure-3).
2. Maintain records of all label verification checks, including signatures of personnel involved in the process, for audit and regulatory inspection purposes.
3. Ensure that the records are maintained for the required retention period as per regulatory guidelines (e.g., five years).

5.5 Label Rejection and Corrective Actions

1. If a label discrepancy is found, stop the packaging process immediately. Investigate the cause of the discrepancy and implement corrective actions.
2. Ensure that the rejected labels are segregated and disposed of according to company procedures to prevent accidental use in the future.
3. All corrective actions taken should be documented, and the process should be monitored to ensure that the issue does not recur (Annexure-4).

5.6 Final Review and Approval

1. Before releasing the packaged product, perform a final check to ensure that all packaging units are correctly labeled with the appropriate product label.
2. Verify that all labeling is compliant with regulatory requirements, including language, dosage instructions, and storage conditions.
3. Once the final check is completed, approve the release of the product for distribution.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• FDA: Food and Drug Administration
• EMA: European Medicines Agency

7. Documents

1. Label Verification Log (Annexure-1)
2. Label Check Report (Annexure-2)
3. Packaging Records (Annexure-3)
4. Corrective Action Report (Annexure-4)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• European Union Guidelines on Good Manufacturing Practice (EU GMP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Label Verification Log

Verification Date	Product Name	Batch Number	Label Verified By	Verification Status
01/03/2026	Tablet A	Batch-12345	John Doe	Verified

Annexure-2: Label Check Report

Batch Number	Label Details	Verified By	Discrepancies Found	Corrective Action
Batch-12345	Correct label applied	Jane Smith	No discrepancies	N/A

Annexure-3: Packaging Records

Product Name	Packaging Date	Packaging Line	Batch Number	Number of Units Packaged
Tablet A	01/03/2026	Line 1	Batch-12345	5000

Annexure-4: Corrective Action Report

Action ID	Issue	Corrective Action	Completion Date
CAPA-001	Incorrect label application	Retrained packaging staff	02/03/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Clarified label verification process	Improved procedures for label checks	QA Head