Standard Operating Procedure for Global Change Control Review for Registered Products
| Department | Regulatory Affairs |
| SOP No. | RA/2026/668 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 11/04/2026 |
| Effective Date | 11/04/2026 |
| Review Date | 11/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes a standardized and controlled process for the comprehensive review and management of global change controls related to registered products. It ensures all post-approval changes, variations, and lifecycle maintenance activities are evaluated, approved, documented, and implemented in compliance with applicable regulatory requirements and internal quality systems. The SOP supports the control objective of maintaining product registration integrity, regulatory compliance, and uninterrupted product supply globally.
Scope
This SOP applies to all regulatory affairs activities related to the initiation, review, evaluation, approval, implementation, and documentation of global change controls for registered pharmaceutical products across all dosage forms and markets. It covers changes affecting product formulations, labeling, manufacturing processes, quality attributes, and regulatory dossiers. The scope includes coordination with cross-functional departments such as Quality Assurance, Quality Control, Manufacturing, Engineering, and Supply Chain. Excluded are local changes that do not impact global registrations or changes solely related to investigational products.
Responsibilities
- Regulatory Affairs: Initiate change control requests, ensure regulatory impact assessment, prepare global submissions, and coordinate reviews.
- Quality Assurance: Review change controls for compliance with GMP and quality systems, approve changes where applicable.
- Quality Control: Provide input on impact of changes on product testing and specifications.
- Manufacturing and Engineering: Assess feasibility and impact of changes on process and equipment.
- Supply Chain/Warehousing: Evaluate impact on product supply and inventory management.
- Documentation Control: Ensure proper document revision, retention, and traceability.
Accountability
The Global Regulatory Affairs Manager holds overall accountability for ensuring implementation, compliance, periodic review, and effectiveness of this SOP. They are responsible for escalation of critical issues, ensuring adequate training, and maintaining records related to global change control reviews.
Procedure
The global change control review process shall be executed in the following stages:
1. Initiation and Preparation
Identify and document the need for change through a formal change control request form. The requestor shall provide sufficient background, rationale, and a preliminary risk assessment. Collate all relevant supporting documentation including current regulatory dossiers, batch records, quality data, and technical specifications.
2. Regulatory Impact and Risk Assessment
The Regulatory Affairs team shall perform a regulatory impact assessment to determine the classification of the change (minor, moderate, or major) and impact on product registrations globally. A cross-functional change control committee shall be involved to evaluate impact on quality, manufacturing, supply, and compliance aspects.
3. Review and Approval
All identified stakeholders shall review the change control documentation, risk evaluations, and regulatory impact. Meetings or workshops may be held to resolve queries. Approval from Quality Assurance and Regulatory Affairs shall be obtained prior to submission or implementation. Changes requiring regulatory submissions shall be subjected to specific internal timelines and approvals based on the target market requirements.
4. Implementation
Upon approval, implementation plans shall be developed outlining responsibilities, timelines, and verification steps. Manufacturing and engineering teams shall execute the change following validated procedures. In-process controls and monitoring shall be performed to ensure change effectiveness and product quality.
5. Documentation and Records
All relevant records including change control requests, approval forms, impact assessments, and validation reports shall be filed and retained as per document control procedures. Updated regulatory dossiers shall be submitted to the competent authorities as required.
6. Post-Implementation Review
After implementation, a review shall be performed to confirm change objectives have been met without adverse impact. Deviations or unexpected outcomes shall be investigated through the deviation management system. Feedback shall be incorporated into continuous improvement programs.
7. Training and Communication
Relevant personnel shall receive training on this SOP and specific changes as applicable. Communication to internal stakeholders and external partners shall be managed to ensure awareness and compliance.
This comprehensive procedure ensures controlled, compliant, and documented management of global changes affecting registered products in alignment with regulatory expectations and business needs.
Abbreviations
- GCC – Global Change Control
- RA – Regulatory Affairs
- QA – Quality Assurance
- QC – Quality Control
- GMP – Good Manufacturing Practices
- SOP – Standard Operating Procedure
- CAPA – Corrective and Preventive Action
- MFR – Manufacturing
Documents
The following documents are required to facilitate and document the global change control review process:
- Global Change Control Request Form (Annexure-1)
- Regulatory Impact Assessment Report (Annexure-2)
- Change Control Approval and Implementation Checklist (Annexure-3)
References
- ICH Q10 – Pharmaceutical Quality System
- FDA Guidance for Industry – Chemistry, Manufacturing, and Controls Changes to an Approved Application
- EMA Guideline on Post-Approval Change Management Protocols (PACMP)
- WHO Technical Report Series – Annex on Change Management
- Internal Quality Manual and Change Control Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Global Change Control Request Form
Purpose: To formally document and initiate the global change control process by capturing the description, rationale, and preliminary assessment of the proposed change.
| Change Control ID | GCC-2026-045 |
| Date of Request | 05/04/2026 |
| Requestor Department | Manufacturing |
| Type of Change | Process Modification |
| Description of Change | Update mixing time in batch process from 60 to 75 minutes to improve consistency |
| Reason for Change | Data from recent batches indicate variability in blend uniformity |
| Preliminary Risk Assessment | Low risk, anticipated improvement in product quality |
| Attachments | Process data reports, batch records |
| Requested By | — |
| Signature | — |
| Date | 05/04/2026 |
Annexure-2: Regulatory Impact Assessment Report
Purpose: To assess and document the potential regulatory impact of the proposed change on global product registrations and submission requirements.
| Change Control ID | GCC-2026-045 |
| Assessment Date | 07/04/2026 |
| Assessed By | — |
| Change Classification | Moderate |
| Impact on Regulatory Submissions | Requires variation submission in EU and stability data update in US |
| Impact on Labeling | No impact |
| Risk to Product Registration | Minimal |
| Comments | Additional stability data collection to be planned |
| Approval Status | Pending |
| Reviewed By | — |
| Date | 08/04/2026 |
Annexure-3: Change Control Approval and Implementation Checklist
Purpose: To verify all required steps have been completed, documents reviewed, and approvals obtained prior to implementation of the change.
| Change Control ID | GCC-2026-045 | |
| Checklist Completion Date | 10/04/2026 | |
| Items | Status | Comments |
| Change Control Request Form Completed | Yes | |
| Regulatory Impact Assessment Completed | Yes | Pending final approval |
| QA Review Completed | Yes | |
| Manufacturing Feasibility Assessed | Yes | |
| Supply Chain Impact Evaluated | Yes | Stock on hand sufficient |
| Training Conducted | Scheduled | To be completed before implementation |
| Implementation Plan Approved | Yes | |
| Signatures: | ||
| Regulatory Affairs | — | Date: 10/04/2026 |
| Quality Assurance | — | Date: 10/04/2026 |
| Manufacturing | — | Date: 10/04/2026 |
| Supply Chain | — | Date: 10/04/2026 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 11/04/2026 | 1.0 | Initial issue | New SOP creation |