Standard Operating Procedure for Review of Missing Misfiled or Duplicate Submission Documents
| Department | Regulatory Affairs |
| SOP No. | RA/2026/778 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 17/04/2026 |
| Effective Date | 17/04/2026 |
| Review Date | 17/04/2028 |
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic and consistent framework for the identification, review, and resolution of missing, misfiled, or duplicate submission documents within regulatory affairs. This SOP supports the control objectives of ensuring data integrity, regulatory compliance, and accurate document management to maintain the quality and reliability of submission dossiers and archives.
Scope
This SOP applies to all regulatory submission documents managed by the Regulatory Affairs department, including electronic and hard copy formats. It covers documents related to regulatory filings, correspondence, dossiers, and archived records for all product types and dosage forms. This SOP excludes document management activities outside submission-related materials or non-regulatory operational records.
Responsibilities
The following roles are involved in this SOP’s execution:
- Regulatory Affairs Executives – Executing initial document review and identification of discrepancies.
- Regulatory Affairs Supervisors – Supervising the review process and coordinating investigations.
- Quality Assurance (QA) – Verifying adherence to documentation control standards and providing final approval.
- Document Control Personnel – Archiving, filing, and updating document status as per outcomes of the review.
- Regulatory Affairs Manager – Oversight and final decision-making on non-conformities or escalations.
Accountability
The Regulatory Affairs Manager is accountable for ensuring compliance with this SOP, overseeing timely implementation, coordinating training and communication, reviewing periodic effectiveness, and escalating issues as needed to quality leadership or compliance committees.
Procedure
1. Preparation and Prerequisites: Prior to initiating review activities, ensure access to the master document list, submission trackers, and archival indices. Verify that personnel conducting the review have received relevant training on documentation and regulatory standards.
2. Identification of Discrepancies: Review submitted and archived documents against submission records to detect discrepancies such as missing documents, misfiled items, or duplicates. Utilize electronic document management systems or physical file audits as applicable.
3. Preliminary Investigation: For any discrepancies detected, the Regulatory Affairs Executive shall initiate a preliminary investigation to understand the nature and cause. This may involve checking document version histories, cross-referencing filing logs, and interviewing involved personnel.
4. Classification of Findings: Categorize findings as missing documents, misfiled documents, or duplicates. Assess potential impact on submission accuracy, compliance, or regulatory timelines.
5. Corrective Actions:
- For missing documents, attempt retrieval from originators or secondary archives. If unrecoverable, initiate documented justification and escalate according to compliance guidelines.
- For misfiled documents, correctly re-file with updated index entries and notify stakeholders.
- For duplicate documents, validate versions and remove or archive duplicates properly to avoid confusion.
6. Verification and Approval: Post corrective actions, the QA department shall verify the resolution, ensuring adherence to good documentation practices and confirm updates to the document control system. The Regulatory Affairs Manager shall approve closure of the issue.
7. Documentation and Record Keeping: All findings, investigations, actions taken, and approvals must be documented using the specified forms and logs listed below. Records shall be maintained in accordance with regulatory retention policies and be readily retrievable for audits.
8. Periodic Review: Conduct periodic reviews (at least annually) of the document management system to detect systemic issues or trends, recommending improvements or training needs as necessary.
9. Deviation Handling: Any deviations from this SOP or unusual discrepancies shall be documented, investigated, and addressed under the deviation management system, with escalation to Quality and Compliance teams.
10. Safety and Compliance Checks: Throughout, ensure adherence to GMP, internal quality standards, and data integrity principles while handling sensitive or confidential regulatory documents.
Abbreviations
QA – Quality Assurance
GMP – Good Manufacturing Practice
SOP – Standard Operating Procedure
RA – Regulatory Affairs
DMS – Document Management System
Documents
The following documents are required for effective implementation of this SOP:
- Submission Document Discrepancy Report (Annexure-1)
- Document Investigation and Resolution Form (Annexure-2)
- Corrective Action Log for Document Management (Annexure-3)
References
• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• EU Annex 11: Computerised Systems
• FDA 21 CFR Part 11: Electronic Records; Electronic Signatures
• PIC/S GMP Guide
• Internal Document Control and Quality Management Policies
• Regulatory Authority Guidelines on Submission Documentation and Archival
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Submission Document Discrepancy Report
Purpose: To formally record and communicate identified discrepancies such as missing, misfiled, or duplicate submission documents during review.
| Report No. | SDDR-2026-001 |
| Date | 17/04/2026 |
| Document Title | Regulatory Submission Dossier – Section 4 |
| Type of Discrepancy | Missing Document |
| Description of Discrepancy | Module 4: Clinical Study Report page missing |
| Identified By | Regulatory Affairs Executive |
| Immediate Action Taken | Notified supervisor and initiated investigation |
| Remarks | Pending retrieval from archive |
Annexure-2: Document Investigation and Resolution Form
Purpose: To document the investigation findings and resolution steps taken for each identified discrepancy in submission documents.
| Investigation No. | INV-2026-053 |
| Date | 18/04/2026 |
| Discrepancy Report Ref. | SDDR-2026-001 |
| Investigation Conducted By | Regulatory Affairs Executive |
| Summary of Findings | Document missing due to archive misplacement, traced to temporary storage area |
| Corrective Action | Relocated document to master archive and updated indexing system |
| Preventive Action | Enhanced archive tracking protocols and conducted staff retraining |
| Verified By QA | |
| Date of Verification | |
| Remarks | Investigation closed and corrective actions approved |
Annexure-3: Corrective Action Log for Document Management
Purpose: To log and track all corrective actions implemented in response to document discrepancies within regulatory submissions.
| Action No. | Date | Discrepancy Ref. | Corrective Action Details | Responsible Person | Completion Date | Verification Status |
|---|---|---|---|---|---|---|
| CA-2026-010 | 19/04/2026 | SDDR-2026-001 | Updated archive location codes and improved physical file security | Document Control Officer | 20/04/2026 | Verified by QA |
| CA-2026-011 | 22/04/2026 | SDDR-2026-001 | Conducted staff refresher training on filing procedures | Regulatory Affairs Supervisor | 24/04/2026 | Verified by QA |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |