Standard Operating Procedure for Managing Label Changes After Health Authority Approval
| Department | Regulatory Affairs |
| SOP No. | RA/2026/750 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 15/04/2026 |
| Effective Date | 15/04/2026 |
| Review Date | 15/04/2028 |
Purpose
This Standard Operating Procedure (SOP) describes the controlled and compliant process for managing and implementing label changes after obtaining Health Authority approval. The purpose is to ensure that all label updates are executed accurately, timely, and in accordance with regulatory requirements to maintain product safety, compliance, and integrity of product information throughout the supply chain.
Scope
This SOP applies to all label changes for pharmaceutical products approved by Health Authorities, including regulatory submissions, artwork revisions, printing, and distribution. It covers all dosage forms, packaging configurations, and associated artwork across all manufacturing sites and regulatory departments involved in regulatory affairs, quality assurance, labeling, and supply chain management. This SOP excludes pre-approval label development activities and non-regulated informational materials.
Responsibilities
- Regulatory Affairs: Initiates and manages the approval communication, coordinates regulatory submissions, and maintains Health Authority correspondence.
- Label Control Team: Executes label artwork revisions, printing approvals, and maintains label versions control.
- Quality Assurance (QA): Reviews and approves label changes ensuring GMP and compliance adherence.
- Production and Warehouse: Verifies receipt of updated labels, implements label replacement, and manages obsolete label destruction.
- Documentation Control: Maintains records of approvals, change requests, and updated label copies.
Accountability
The Head of Regulatory Affairs is accountable for ensuring compliance with this SOP, overseeing the implementation of label changes, periodic review of process effectiveness, escalation of discrepancies, and ensuring alignment with Health Authority requirements.
Procedure
1. Preparation and Prerequisites:
Upon receipt of approved label change notification from Health Authority, Regulatory Affairs shall obtain formal written approval documentation and communicate the change to relevant stakeholders, including Label Control, QA, Production, and Warehouse.
2. Change Request and Documentation:
Regulatory Affairs initiates a Label Change Request form detailing approved modifications. The request must be logged into the change management system and trigger cross-functional review.
3. Artwork Revision:
The Label Control Team revises label artwork reflecting approved changes, ensuring compliance with approved versions. A proof copy must be generated for review.
4. Quality Review and Approval:
QA reviews the modified artwork compared against approved Health Authority communications to verify conformity with regulatory and GMP standards. QA approval must be documented.
5. Label Printing and Control:
Following QA approval, Label Control releases the label batch for printing with printing logs maintained. Printed labels must be verified for accuracy, print quality, and absence of unauthorized alterations.
6. Implementation in Production and Warehouse:
Production and Warehouse personnel receive updated labels and must verify their authenticity and approval status before use. Obsolete labels are securely quarantined and destroyed following documented procedures.
7. Communication and Training:
Regulatory Affairs coordinates communication to affected functional areas on the implementation timeline, and training is provided if procedural changes are necessary.
8. Record Keeping:
All documentation including Health Authority approvals, change requests, artwork files, QA approvals, printing records, and destruction certificates shall be retained as per company document retention policy.
9. Deviations and Corrections:
Any deviations from this procedure must be documented, investigated, and approved following the company’s deviation management process.
10. Periodic Review:
The effectiveness and compliance of this SOP shall be reviewed at least biennially or following major regulatory changes impacting labelling requirements.
Abbreviations
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- HA: Health Authority
- RA: Regulatory Affairs
Documents
- Label Change Request Form (Annexure-1)
- Label Artwork Approval Checklist (Annexure-2)
- Label Printing Log and Verification Record (Annexure-3)
- Obsolete Label Destruction Certificate (Annexure-4)
References
International Council for Harmonisation (ICH) Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients; FDA 21 CFR Part 11 – Electronic Records; EU Annex 11 on Computerised Systems; WHO Technical Report Series – Good Manufacturing Practices for Pharmaceutical Products; Company Quality Management System; Local Health Authority guidance documents on labeling requirements.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Label Change Request Form
Purpose: To formally request and document label changes approved by Health Authority.
| Request No. | LCR-2026-001 |
| Date of Request | 15/04/2026 |
| Product Name | Example Product |
| Batch/Lot Number | N/A |
| Description of Label Change | Update to storage instructions as per HA approval dated 10/04/2026 |
| Health Authority Approval Reference | HA/APP/2026/105 |
| Requested By (Function) | Regulatory Affairs |
| Reviewed By (QA) | |
| Approval Status | Pending |
| Remarks |
Annexure-2: Label Artwork Approval Checklist
Purpose: To ensure all regulatory and GMP requirements are met prior to printing revised label artwork.
| Checklist Item | Compliance Confirmed | Remarks |
|---|---|---|
| Match with HA approved version | Yes | |
| Correct product name and dosage form | Yes | |
| Legible font size and formatting | Yes | |
| Regulatory required statements included | Yes | |
| Barcodes and batch coding reviewed | Yes | |
| QA reviewed and approved | Pending |
Annexure-3: Label Printing Log and Verification Record
Purpose: To document printing details and verification of label batches before release to production.
| Print Batch No. | LBP-2026-045 |
| Date of Printing | 20/04/2026 |
| Printer Operator | |
| Number of Labels Printed | 10,000 |
| QA Verification Status | Pending |
| Verification Date | |
| Remarks |
Annexure-4: Obsolete Label Destruction Certificate
Purpose: To certify secure destruction of obsolete label inventory to prevent unintended use.
| Destruction Certificate No. | ODC-2026-009 |
| Destruction Date | 25/04/2026 |
| Obsolete Label Batch Number(s) | LBP-2025-210 |
| Quantity Destroyed | 5,000 labels |
| Method of Destruction | Shredding and incineration |
| Witnessed By (QA) | |
| Remarks |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |