Standard Operating Procedure for Regulatory Document Management and Controlled Storage
| Department | Regulatory Affairs |
| SOP No. | RA/2026/764 |
| 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) defines the systematic controls and management processes for regulatory documents and their controlled storage to ensure data integrity, traceability, security, and compliance with applicable regulatory requirements. It aims to establish consistent procedures for handling creation, review, approval, archival, retrieval, and disposal of regulatory documents supporting regulatory submissions and quality systems.
Scope
This SOP applies to all regulatory documents including registrations, submissions, correspondence, approvals, and supporting records handled by the Regulatory Affairs department. It covers electronic and hardcopy documents stored within designated controlled storage areas and electronic document management systems (EDMS). Activities related to document lifecycle management such as creation, review, revision, archival, retrieval, retention, and disposal are included. Documents and storage outside Regulatory Affairs or unrelated to regulatory compliance are excluded.
Responsibilities
The following roles shall execute this SOP: Regulatory Affairs Associates for document preparation and filing; Regulatory Affairs Specialists for review and approval; Document Control personnel for maintenance and archival; Quality Assurance for oversight and periodic audits; and Department Managers for supervision and compliance monitoring.
Accountability
The Head of Regulatory Affairs is accountable for the implementation, compliance, periodic review, escalation of deviations, and assessment of the effectiveness of this SOP to ensure regulatory document integrity and controlled storage is maintained as per applicable guidelines and company policy.
Procedure
1. Preparation and Creation: Regulatory documents shall be created by authorized personnel using approved templates and formats ensuring accuracy, completeness, and legibility. Each document must be uniquely identified with a title, version number, date, and responsible author.
2. Review and Approval: Completed documents shall undergo a thorough review by designated Regulatory Affairs Specialists or Subject Matter Experts to verify content correctness and compliance. Documents shall be approved using electronic signature or physical sign-off following company policies before distribution or submission.
3. Document Control: Documents shall be entered into a master document register or EDMS immediately after approval. Document Control personnel shall verify metadata, assign storage locations, and control access permissions according to sensitivity and confidentiality.
4. Controlled Storage: All regulatory documents, whether electronic or physical, must be stored in designated controlled storage areas or secure electronic repositories with restricted access to authorized personnel only. Physical storage conditions shall prevent damage, loss, or unauthorized access, incorporating fireproof filing cabinets or climate control if required.
5. Retrieval and Use: Authorized users may retrieve documents for official use following documented request and access protocols. Any copies made shall be dated, marked “copy,” and traceable. Strict version control shall be maintained to ensure only current documents are in operational use.
6. Periodic Review and Archival: Documents shall be periodically reviewed for continued relevance and update needs. Superseded or obsolete versions shall be removed from active storage and archived separately with restricted access. Archival timelines shall comply with applicable regulation and company retention policies.
7. Document Disposal: At the end of the retention period, documents shall be disposed of securely ensuring confidentiality is maintained. Disposal activities shall be documented and authorized by the Responsible Person.
8. Deviations and Corrections: Any deviations or discrepancies related to document management or storage must be documented, investigated, and corrected promptly with escalation to management and QA, where applicable.
9. Training and Compliance: All personnel involved shall receive training on this SOP and demonstrate understanding. Compliance audits shall be conducted periodically to verify adherence.
10. Documentation and Record Keeping: Records of document creation, review, approval, storage location, retrieval, archival, disposal, and training must be maintained for audit trail and traceability.
Abbreviations
RA – Regulatory Affairs
SOP – Standard Operating Procedure
EDMS – Electronic Document Management System
QA – Quality Assurance
GMP – Good Manufacturing Practice
Documents
Specific documents required for this SOP activity include:
- Regulatory Document Register (Annexure-1)
- Document Review and Approval Form (Annexure-2)
- Document Retrieval and Access Log (Annexure-3)
References
International Conference on Harmonisation (ICH) Q7 & Q10 guidelines, FDA 21 CFR Part 11, EMA guidelines on computerized systems, Good Documentation Practices (GDP), Company Documentation Control Policy, and relevant national regulatory standards.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Document Register
Purpose: To maintain a comprehensive log of all regulatory documents created, approved, stored, and archived for traceability and quick retrieval.
| Document ID | Document Title | Version | Creation Date | Approval Date | Storage Location | Status |
|---|---|---|---|---|---|---|
| RA-REG-001 | Registration Dossier | 3.0 | 01/02/2026 | 10/02/2026 | EDMS Folder RA Documents | Active |
| RA-CORR-014 | Regulatory Correspondence | 1.2 | 15/03/2026 | 20/03/2026 | Physical Filing Cabinet 3 | Active |
| RA-APP-007 | Marketing Authorization Approval | 1.0 | 05/04/2026 | 12/04/2026 | EDMS Folder RA Approvals | Active |
Annexure-2: Document Review and Approval Form
Purpose: To document the review and approval process for regulatory documents ensuring completeness, accuracy, and regulatory compliance before release.
| Document ID: | RA-REG-001 |
| Document Title: | Registration Dossier |
| Version: | 3.0 |
| Prepared By: | Regulatory Affairs Associate |
| Checked By: | Regulatory Affairs Specialist |
| Approved By: | Regulatory Affairs Manager |
| Review Date: | 10/02/2026 |
| Comments: Document content verified for regulatory compliance; no discrepancies found. | |
Annexure-3: Document Retrieval and Access Log
Purpose: To record details of all retrievals and accesses of regulatory documents from controlled storage to maintain audit trails and ensure controlled usage.
| Date | Document ID | Requested By | Purpose of Access | Returned Date | Remarks |
|---|---|---|---|---|---|
| 15/04/2026 | RA-REG-001 | Regulatory Affairs Associate | Review prior to submission | 16/04/2026 | Returned in good condition |
| 20/04/2026 | RA-CORR-014 | Regulatory Affairs Specialist | Audit support | 21/04/2026 | No issues noted |
| 22/04/2026 | RA-APP-007 | Regulatory Affairs Manager | Verification of approvals | 23/04/2026 | Verified and returned |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 16/04/2026 | 1.0 | Initial issue | New SOP creation |