Standard Operating Procedure for Periodic Review of Archived Regulatory Files
| Department | Regulatory Affairs |
| SOP No. | RA/2026/772 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 17/04/2026 |
| Effective Date | 17/04/2026 |
| Review Date | 17/04/2028 |
Purpose
This Standard Operating Procedure (SOP) defines the systematic process for the periodic review of archived regulatory files to ensure their continued integrity, completeness, legibility, and compliance with applicable regulatory and internal quality standards. This SOP supports maintaining data integrity, regulatory compliance, and readiness for audits and inspections by establishing control measures for timely and effective evaluation of all archived regulatory documents.
Scope
This SOP applies to all archived regulatory files maintained within the Regulatory Affairs department, including submission dossiers, correspondence, approvals, licenses, change control records, and related documentation across all products and dosage forms. The procedure encompasses physical and electronic archives relevant to any regulatory process. Activities outside Regulatory Affairs, non-regulatory documents, and real-time operational records are excluded from this SOP.
Responsibilities
- Regulatory Affairs Document Control Coordinator: Executes the periodic review process and maintains records.
- Regulatory Affairs Quality Assurance: Reviews the monitoring outcomes for compliance and effectiveness.
- Regulatory Affairs Supervisor/Manager: Oversees execution, approves corrective actions, and ensures resources.
- Compliance & Audit Team: Verifies through audit whether periodic review is appropriately implemented.
Accountability
The Regulatory Affairs Head holds overall accountability for the implementation, compliance, periodic review, escalation of issues discovered during the archived files evaluation, and ensuring ongoing effectiveness of this SOP.
Procedure
1. Preparation
Identify the archived regulatory files due for periodic review according to the archival retention schedule. Notify involved personnel and allocate resources to conduct the review within the defined timeframe.
2. Prerequisites
Confirm access permissions to the archived physical locations and electronic document management systems. Verify the availability of relevant tools such as checklist forms and ensure personnel are trained in data integrity and archival requirements.
3. Safety and GMP Checks
Ensure all GMP and safety protocols are observed when handling physical archived files. Maintain confidentiality and data security in line with regulatory requirements during review.
4. Execution Steps
a. Retrieve files listed for review, including both physical and electronic records.
b. Inspect each file for completeness, verifying presence of all required documents, proper indexing, and secure binding.
c. Assess legibility of all documents, including signatures, stamps, and annotations.
d. Confirm documents are stored under appropriate conditions to prevent deterioration.
e. Evaluate compliance with retention timelines and note any files approaching disposal or extended retention.
5. In-Process Controls and Verification
Cross-check findings against the archival checklist to assure all checkpoints are met. Any missing documentation, damage, or non-compliance must be documented.
6. Acceptance Criteria
Files must be complete, legible, securely stored, and compliant with archival policies. Any deviations identified require documented corrective actions.
7. Deviations and Corrective Actions
Report deviations immediately to the Regulatory Affairs Supervisor. Initiate corrective and preventive actions (CAPA) for retrieval of missing documents, repair, or repackaging of damaged files.
8. Approvals and Documentation
Complete the Periodic Review Checklist (Annexure-1) for each batch of files reviewed and obtain sign-off from the Regulatory Affairs Supervisor and QA Reviewer.
9. Record Retention
Retain completed checklists, deviation reports, and CAPA records alongside archived files as per document retention policy.
10. Closure
Update the archive inventory records to reflect review status and schedule next periodic review according to policy. Submit summary reports to Regulatory Affairs Head for review and compliance monitoring.
This methodology ensures that archived regulatory files remain compliant, intact, and readily retrievable to support regulatory inspections, audits, and submissions at all times.
Abbreviations
- CAPA: Corrective and Preventive Action
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- RA: Regulatory Affairs
Documents
The following documents are required for the effective implementation of this SOP:
- Periodic Review Checklist for Archived Regulatory Files (Annexure-1)
- Deviation Report Form related to Archived Files (Annexure-2)
- Corrective and Preventive Action (CAPA) Form (Annexure-3)
References
- ICH Q7 Good Manufacturing Practice Guide
- EU GMP Annex 11 – Computerised Systems
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- WHO Technical Report Series on Data Integrity
- Internal Document Control and Archival Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Periodic Review Checklist for Archived Regulatory Files
Purpose: To document the review status of archived regulatory files ensuring completeness, legibility, and compliance.
| Review Date | 10/04/2026 | |
|---|---|---|
| File Reference No. | RA-DOC-2024-015 | |
| Product / Submission | Product A – Marketing Authorization | |
| Reviewer Name/ID | ||
| Checklist Items | Status (Yes/No) | Comments |
| All documents complete and present | Yes | |
| Documents legible and signed | Yes | |
| Proper indexing and labels used | Yes | |
| Stored as per archival conditions | Yes | |
| No physical damage observed | Yes | |
| Retention period compliance confirmed | Yes |
Reviewer Signature: ________________________ Date: 10/04/2026
Annexure-2: Deviation Report Form related to Archived Files
Purpose: To record any deviations or discrepancies identified during periodic review of archived regulatory files.
| Deviation Report No. | DEV-RA-2026-034 |
|---|---|
| Date of Detection | 10/04/2026 |
| File Reference No. | RA-DOC-2023-089 |
| Description of Deviation | Missing correspondence letter regarding submission amendment. |
| Immediate Action Taken | Initiated search for missing document and informed supervisor. |
| Root Cause Analysis | Document misfiled during last archive update. |
| Preventive Action Proposed | Implement barcode system for tracking file movements. |
| Reported By | |
| Approved By |
Annexure-3: Corrective and Preventive Action (CAPA) Form
Purpose: To document corrective and preventive actions taken in response to deviations found during review of archived regulatory files.
| CAPA No. | CAPA-RA-2026-012 |
|---|---|
| Date Initiated | 12/04/2026 |
| Related Deviation No. | DEV-RA-2026-034 |
| Description of Corrective Action | Located and re-filed missing correspondence in proper archive location. |
| Description of Preventive Action | Started implementation of new archival tracking barcode system with staff training. |
| Effectiveness Review Date | 12/10/2026 |
| Outcome of Effectiveness Review | Pending |
| CAPA Verified By | |
| CAPA Approved By |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 17/04/2026 | 1.0 | Initial issue | New SOP creation |