Standard Operating Procedure for Replacing Incorrect Files in Submission Sequences
| Department | Regulatory Affairs |
| SOP No. | RA/2026/696 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 12/04/2026 |
| Effective Date | 12/04/2026 |
| Review Date | 12/04/2028 |
Purpose
This Standard Operating Procedure (SOP) outlines the controlled and systematic process for identifying, managing, and replacing incorrect files found within electronic submission sequences prior to final regulatory submission. It ensures the maintenance of submission quality, data integrity, timely corrections, and compliance with regulatory requirements governing eCTD publishing and submission management.
Scope
This SOP applies to all Regulatory Affairs personnel involved in preparing, reviewing, and publishing electronic Common Technical Document (eCTD) submissions, specifically focusing on the identification and replacement of incorrect or outdated files within submission sequences. It includes activities related to submission quality control, data management, and final dispatch. This procedure excludes non-electronic submissions, post-submission regulatory communications, and unrelated documentation processes.
Responsibilities
The following roles are involved in this SOP:
- Regulatory Affairs Coordinator – Executes file replacement process including identification, correction, and uploading of files.
- Quality Control Reviewer – Performs verification and approval of file replacements ensuring compliance with submission standards.
- Regulatory Affairs Manager – Supervises the overall process and ensures adherence to timelines and regulatory expectations.
- Document Control – Maintains records of all file replacements and updates control logs.
Accountability
The Regulatory Affairs Head is accountable for ensuring the effective implementation of this SOP, compliance with all procedural requirements, regular review and updates of the procedure, escalation of deviations or non-compliances, and ensuring periodic effectiveness assessments are conducted.
Procedure
Preparation and Prerequisites:
Prior to initiating the file replacement, confirm that the submission sequence has been reviewed and that an incorrect file has been formally identified through quality control checks, audit outcomes, or regulatory feedback. Ensure all involved personnel have access to the appropriate submission management software and have requisite permissions. Verify that backup copies of the original submission sequence are securely maintained as per data retention policy.
Safety and Compliance Checks:
Confirm compliance with applicable regulatory guidelines related to electronic submissions (e.g., eCTD guidance). Conduct a risk assessment if the file replacement could impact critical submission data, and obtain necessary managerial approvals to proceed.
Execution Steps:
1. Access the submission management system and navigate to the specific sequence containing the incorrect file.
2. Document the details of the incorrect file including location, document name, sequence number, and version.
3. Retrieve the correct or updated file version from the validated document repository ensuring it meets acceptance criteria.
4. Replace the incorrect file within the submission sequence using the system tools designed for eCTD publishing.
5. Update the submission sequence map or index files as necessary to reflect the file replacement.
6. Record the replacement action in the File Replacement Log with all relevant details including date, reason, and personnel involved.
In-Process Controls and Verification:
After replacement, conduct a detailed QC check of the updated sequence to verify:
– Correct file incorporation and accessibility.
– Compliance with submission formatting and metadata requirements.
– Absence of broken links or inconsistencies within the sequence.
Document the verification outcome clearly in the QC checklist and get sign-off from the Quality Control Reviewer.
Deviations and Approvals:
If any deviation or unexpected issue arises during replacement, immediately report and escalate as per deviation handling procedures. Obtain necessary approvals before proceeding further.
Documentation and Record Retention:
Ensure all actions are fully documented including:
– Replacement logs
– QC checklists
– Approval records
These documents must be retained securely according to company document retention policies to ensure traceability and audit readiness.
Closure:
Upon successful replacement and verification, finalize the submission sequence for dispatch or further processing. Notify relevant stakeholders of the corrected files and update any submission tracking systems accordingly.
Abbreviations
eCTD – electronic Common Technical Document
QC – Quality Control
SOP – Standard Operating Procedure
ID – Identification
RA – Regulatory Affairs
Documents
- File Replacement Log (Annexure-1)
- Submission Sequence QC Checklist (Annexure-2)
- Deviation Report Form (Annexure-3)
References
ICH M2 eCTD Specifications, FDA Electronic Submission Standards, EMA Regulatory Submission Guidelines, Company Quality Management System Documentation, GMP Documentation Control Procedures, 21 CFR Part 11 – Electronic Records and Signatures.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: File Replacement Log
Purpose: To document all details related to the replacement of incorrect files within submission sequences, ensuring traceability and accountability.
| Date | Sequence No. | Incorrect File Name | Replacement File Name | Reason for Replacement | Performed By | Verified By |
|---|---|---|---|---|---|---|
| 10/04/2026 | Seq005 | CTD_Module3_Section1.pdf | CTD_Module3_Section1_Rev2.pdf | Updated stability data included | RegAff Coord. | QC Reviewer |
| 11/04/2026 | Seq006 | Labeling_v1.docx | Labeling_Final.docx | Corrected product name typo | RegAff Coord. | QC Reviewer |
Annexure-2: Submission Sequence QC Checklist
Purpose: To verify that file replacements in the submission sequence meet acceptance criteria and comply with regulatory and company standards.
| Sequence No. | File Name | Replacement Verified (Y/N) | Format and Metadata Correct (Y/N) | Links Verified (Y/N) | Reviewer Comments | Date | Reviewed By |
|---|---|---|---|---|---|---|---|
| Seq005 | CTD_Module3_Section1_Rev2.pdf | Y | Y | Y | File integrated correctly, no issues found | 11/04/2026 | QC Reviewer |
| Seq006 | Labeling_Final.docx | Y | Y | Y | Typo corrected, sequence index updated | 12/04/2026 | QC Reviewer |
Annexure-3: Deviation Report Form
Purpose: To record any deviations encountered during the file replacement process and the corrective actions taken.
| Deviation ID | Date | Description of Deviation | Impact Assessment | Root Cause | Corrective Actions | Approval Status | Approved By |
|---|---|---|---|---|---|---|---|
| DEV-RA-001 | 11/04/2026 | File upload failed due to system error | Minor delay in sequence finalization | Network connectivity issue | Re-upload after connectivity restored; notified IT support | Approved | Reg Affairs Head |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |