Standard Operating Procedure for Label Consistency Check Across Countries

Department	Regulatory Affairs
SOP No.	RA/2026/762
Supersedes	NA
Page No.	1 of X
Issue Date	16/04/2026
Effective Date	16/04/2026
Review Date	16/04/2028

Purpose

This Standard Operating Procedure (SOP) establishes a consistent and systematic approach for verifying and ensuring that product labels, artwork, and regulatory information remain uniform and accurate across different countries where the product is marketed. It aims to prevent label discrepancies that could lead to regulatory non-compliance, product recalls, or negative impacts on product safety and efficacy. This SOP supports compliance with regulatory requirements for label harmonization and ensures high-quality documentation control throughout the labelling lifecycle.

Scope

This SOP applies to all labelling, artwork, and associated product information developed and utilized by the Regulatory Affairs department for pharmaceutical products distributed across multiple countries. It encompasses all dosage forms and presentations, including packaging components such as cartons, inserts, leaflets, and labels. The procedure is applicable from label creation, review, approval, to final release stages before product distribution. Activities outside regulatory labelling reviews, such as commercial marketing materials or non-product-specific documentation, are excluded.

Responsibilities

The following roles are involved in the label consistency check process:

• Regulatory Affairs Analysts – execute detailed comparisons and initial reviews of label content and artwork across country versions.
• Regulatory Affairs Reviewers – conduct secondary reviews and ensure compliance with local regulatory requirements.
• Quality Assurance – supervise the review process, verify adherence to SOP, and approve release of consistent label versions.
• Artwork / Design Teams – implement requested changes and maintain label templates conforming to regulatory specifications.
• Documentation Control – maintain records and archive all documentation related to label consistency checks.

Accountability

The Regulatory Affairs Head is accountable for the overall implementation and compliance with this SOP. This role ensures periodic review and update of the procedure, oversees escalation of deviations or discrepancies, and confirms the effectiveness of controls for label consistency verification within the jurisdictional regulatory framework.

Procedure

The label consistency check must be performed systematically to identify and correct discrepancies prior to product distribution across countries. The procedure includes the following stages:

1. Preparation

• Obtain all label versions and related artwork files for the countries involved from the document management system or artwork team.
• Gather the applicable country-specific regulatory requirements, reference labels, and approved product information documents.
• Ensure the review environment complies with data integrity and confidentiality standards.

2. Prerequisites

• Confirm that label drafts have passed prior internal reviews and approvals, including language and translation verifications.
• Verify that all source documents and regulatory dossiers used for reference are current and approved.

3. Execution of Label Consistency Check

• Conduct a side-by-side comparison focusing on mandatory content such as product name, dosage strength, manufacturer details, batch number format, expiry date, warnings, storage conditions, and regulatory statements.
• Cross-verify barcodes, graphics, fonts, colors, and layout to ensure visual uniformity unless justified by regulatory or local language requirements.
• Highlight discrepancies and prepare a detailed comparison report outlining the differences and proposed resolutions.
• Consult with cross-functional teams (QA, Regulatory, Artwork) for clarification and corrective actions.

4. In-Process Controls and Approvals

• Implement agreed changes, and have all updated label versions re-reviewed and approved by Regulatory Affairs and QA before final release.
• Ensure all approvals are documented, including electronic or manual signatures with timestamps.

5. Documentation and Record Retention

• Archive comparison reports, approval records, final label files, and communication logs in compliance with company policies and regulatory requirements.
• Maintain traceability of the review and approval process for audit readiness.

6. Deviations and Escalations

• Any unexplained label deviations or unresolved discrepancies must be documented as deviations and escalated promptly to the Regulatory Affairs Head and Quality Assurance.
• Implement CAPA as necessary to address root causes and prevent recurrence.

7. Closure

• Confirm closure of the label consistency check activity through final review meetings and update the SOP or related procedures if required based on lessons learned.
• Communicate finalized label versions to manufacturing and distribution to enable compliant product release.

Abbreviations

GMP – Good Manufacturing Practice
CAPA – Corrective and Preventive Actions
QA – Quality Assurance
RA – Regulatory Affairs
SOP – Standard Operating Procedure

Documents

The following documents are required to perform and document the label consistency check process effectively:

1. Label Consistency Comparison Report Template (Annexure-1)
2. Label Review and Approval Record (Annexure-2)
3. Label Deviation and CAPA Form (Annexure-3)

References

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
EMA/CHMP Quality Guidelines on Labelling
FDA Guidance for Industry: Container Labeling
Company Quality Manual: Documentation and Change Control Procedures
Local Regulatory Health Authority Labeling Requirements

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Label Consistency Comparison Report Template

Purpose: To systematically document differences found during label comparisons across countries and track resolutions.

Field	Description / Dummy Data
Report ID	LCCR-RA-2026-001
Date of Review	10/04/2026
Reviewed By	Regulatory Affairs Analyst
Product Name	Product X – Oral Tablets
Countries Compared	Country A, Country B, Country C
Label Version Numbers	V5.2, V5.1, V5.3
Comparison Summary	Country B expiry date format differs (MM/YYYY vs DD/MM/YYYY) Manufacturer address differs for Country C Warning statements consistent across all versions Barcode symbology uniform
Discrepancies Found	Address mismatch for Country C Expiry date format inconsistency
Corrective Actions Proposed	Align Country C address with master template; standardize expiry format to DD/MM/YYYY after regulatory confirmation.
Remarks	Awaiting final approval from local regulatory offices.
Sign-Off	Pending

Annexure-2: Label Review and Approval Record

Purpose: To record the review and formal approval of label versions post consistency check prior to release.

Field	Description / Dummy Data
Product Name	Product X – Oral Tablets
Label Version	V5.3
Date of Final Review	15/04/2026
Reviewer Role	Regulatory Affairs Reviewer
Comments	All discrepancies resolved. Label aligned across countries.
Approval Status	Approved for Release
Signature	Electronically Signed
Date of Approval	15/04/2026

Annexure-3: Label Deviation and CAPA Form

Purpose: To document any deviations identified during label consistency checks and track corrective/preventive actions.

Field	Description / Dummy Data
Deviation ID	DEV-LAB-2026-015
Date of Deviation	12/04/2026
Description of Deviation	Mismatch in expiry date format not resolved prior to label release.
Impact Assessment	Potential regulatory non-compliance and market delay.
Immediate Correction	Notified artwork team to hold printing. Informed regulatory authorities.
Root Cause Analysis	Inadequate cross-country communication during review phase.
CAPA Actions	Implement checklist for mandatory cross-country verification steps.
Completion Date	20/04/2026
Status	Closed
Reviewed By	Quality Assurance
Approved By	Regulatory Affairs Head

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
16/04/2026	1.0	Initial issue	New SOP creation