Standard Operating Procedure for Version Control of Regulatory Submission Documents
| Department | Regulatory Affairs |
| SOP No. | RA/2026/765 |
| 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 controlled and consistent process for version control of regulatory submission documents to ensure document integrity, traceability, accuracy, and compliance with applicable regulatory requirements. The objective is to maintain a clear record of document revisions, prevent unauthorized changes, and support audit readiness for submissions to health authorities and other regulatory bodies.
Scope
This SOP applies to all regulatory submission documents generated, reviewed, approved, and archived by the Regulatory Affairs department. It covers all formats and dosage forms of submission documents related to product registrations, amendments, renewals, and supplements. The SOP is applicable to version control activities including document numbering, revision tracking, distribution, and archiving across all regulated functional areas involved in regulatory submissions. This SOP excludes documents outside regulatory submissions such as internal procedural documents not submitted externally.
Responsibilities
The following roles are involved in the version control process:
- Regulatory Affairs Document Owner: Prepare, revise, and submit documents for approval.
- Reviewers: Examine document content for accuracy, completeness, and regulatory compliance.
- Approvers: Authorize and approve finalized document versions prior to submission or archiving.
- Document Control Coordinator: Maintain version tracking logs, apply correct version numbers, and distribute updated documents.
- Quality Assurance: Monitor adherence to version control procedures during audits and reviews.
Accountability
The Head of Regulatory Affairs is accountable for the implementation, compliance, regular review, escalation of issues, and continuous improvement of this SOP to ensure the effective control of regulatory submission document versions.
Procedure
1. Preparation and Document Creation:
The document owner drafts the regulatory submission document using the latest approved templates and guidelines. All source data must be verified for accuracy and relevance. Initial versioning shall start at Version 1.0 or as per the document numbering protocol.
2. Document Numbering and Version Assignment:
Each regulatory submission document will be assigned a unique document identification number reflecting its category and submission type. Version numbers shall follow a decimal format (e.g., 1.0, 1.1) indicating major and minor revisions respectively. New submissions use initial version 1.0, while revisions increment as appropriate.
3. Review and Approval:
The document undergoes thorough review by designated reviewers to ensure compliance and accuracy. Review comments must be documented and addressed in subsequent revisions. Upon satisfactory review, the document is submitted for approval. Approvers verify final content, version accuracy, and compliance before sign-off. Approval is only granted for finalized documents.
4. Document Revision and Change Control:
Any changes after approval require documented revision, citing reason for change, and the issuance of a new version number. Changes must be controlled and documented to prevent unauthorized updates. Minor editorial changes may increment minor version numbers; significant content changes require major version increments.
5. Distribution and Access Control:
After approval, controlled copies of the document will be distributed to relevant stakeholders. Electronic document management systems or controlled folders shall be used to restrict access to the latest approved version only. Obsolete versions must be withdrawn from active use but retained per archiving standards.
6. Record Retention and Archiving:
All versions of regulatory submission documents along with review and approval records must be archived securely as per regulatory requirements and internal retention policies. Archived documents must be retrievable and protected against damage, loss, or unauthorized alteration.
7. Deviation and Non-conformance Handling:
Any deviations from the version control process must be documented, investigated, and approved by Quality Assurance. Actions taken to prevent recurrence shall be implemented and monitored.
8. Periodic Review:
Version control records and the effectiveness of this SOP shall be reviewed periodically as part of the quality management review to ensure continuous compliance and improvement in document control practices.
Abbreviations
SOP – Standard Operating Procedure
RA – Regulatory Affairs
QA – Quality Assurance
GMP – Good Manufacturing Practice
Documents
- Regulatory Submission Document Version Control Log (Annexure-1)
- Regulatory Submission Document Change Request Form (Annexure-2)
- Document Approval and Review Checklist (Annexure-3)
References
1. ICH Q10 Pharmaceutical Quality System
2. FDA Guidance for Industry: Good Automated Manufacturing Practice (GAMP)
3. EMA Guidelines on Quality Systems and Documentation
4. Internal Quality Management System Documentation Control Procedures
5. Relevant Pharmacopoeial Requirements and Regulatory Agency Expectations
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Submission Document Version Control Log
Purpose: To record and track all versions of regulatory submission documents including version number, effective date, changes, and responsible personnel.
| Document ID | Document Title | Version | Effective Date | Change Description | Prepared By | Reviewed By | Approved By |
|---|---|---|---|---|---|---|---|
| RS-2026-001 | New Drug Application Module 3 | 1.0 | 16/04/2026 | Initial Release | Regulatory Affairs Team | Regulatory Review Committee | Head of Regulatory Affairs |
| RS-2026-001 | New Drug Application Module 3 | 1.1 | 01/06/2026 | Updated stability data section | Regulatory Affairs Team | Regulatory Review Committee | Head of Regulatory Affairs |
Annexure-2: Regulatory Submission Document Change Request Form
Purpose: To formally request and document proposed changes to an existing regulatory submission document version.
| Change Request No. | CR-2026-015 |
|---|---|
| Document ID | RS-2026-001 |
| Current Version | 1.1 |
| Description of Change | Correction of typographic errors in clinical data tables |
| Reason for Change | To enhance clarity and prevent misinterpretation |
| Requested By | Regulatory Affairs Team |
| Date of Request | 10/07/2026 |
| Review Comments | Reviewed and accepted for minor revision |
| Approval Status | Approved |
| Approval Date | 12/07/2026 |
| Approved By | Head of Regulatory Affairs |
Annexure-3: Document Approval and Review Checklist
Purpose: To ensure all required review and approval steps are completed before document version release.
| Checklist Item | Yes/No | Comments |
|---|---|---|
| Document prepared as per latest templates | Yes | |
| All data verified for accuracy | Yes | |
| Reviewed by Regulatory Review Committee | Yes | |
| Compliance with current regulatory guidelines confirmed | Yes | |
| Version number correctly assigned | Yes | |
| Approval signatures obtained | Yes | |
| Document distributed to all relevant departments | Yes | |
| Obsolete versions archived and withdrawn from use | Yes | |
| Record retention compliance checked | Yes |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 16/04/2026 | 1.0 | Initial issue | New SOP creation |