Standard Operating Procedure for Archival and Retrieval of Approved Dossiers

Department	Regulatory Affairs
SOP No.	RA/2026/766
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 processes and controls for the systematic archival and retrieval of approved regulatory dossiers to ensure secure, organized, and compliant management of regulatory documentation. The objective is to maintain the integrity, availability, and confidentiality of approved dossiers throughout their retention period in alignment with regulatory requirements and internal quality systems.

Scope

This SOP applies to all approved regulatory dossiers including submissions, correspondence, approvals, and regulatory documentation across all product types, dosage forms, and therapeutic areas managed by the Regulatory Affairs department. It covers procedures for physical and electronic archival, retrieval, handling, and disposal authorized by regulatory guidelines. Excluded from the scope are draft dossiers, non-regulatory records, and documents managed exclusively by other departments unless explicitly referenced herein.

Responsibilities

The following roles are involved within this procedure:
– Regulatory Affairs Associates and Executives: Execute archival and retrieval activities as per this SOP.
– Quality Assurance: Review and audit the archival process for compliance.
– Regulatory Affairs Manager: Supervise and authorize archival and retrieval operations.
– Document Control Coordinator: Maintain master logs and track dossier statuses.
– IT Support: Ensure secure electronic storage and access controls.

Accountability

The Regulatory Affairs Head (or designated senior management) is accountable for overall implementation, SOP compliance, periodic review, escalation of issues, and continuous improvement of this archival and retrieval process.

Procedure

1. Preparation and Prerequisites:
Before archival, ensure that all dossiers are complete, approved, and validated per regulatory requirements. Confirm that all relevant product information, submission numbers, and associated metadata are finalized and documented.

2. Archival Process:
a. Physical Dossiers:
– Verify approval and completeness.
– Label dossiers with unique identifiers including product code, dossier type, and archival date.
– Store physical dossiers in designated secure areas with restricted access.
– Update physical archival logbook and electronic master tracking system.

b. Electronic Dossiers:
– Ensure files are in approved formats (PDF or regulatory compliant formats).
– Apply metadata tags for easy identification.
– Upload dossiers onto secure validated document management system.
– Confirm backup and data integrity verification.
– Log archival details in the electronic archival database.

3. Retrieval Process:
– Receipt of retrieval request must be documented using the approved form.
– Verify requestor’s authorization.
– Identify dossier location and verify dossier integrity.
– For physical dossiers, retrieve from storage by authorized personnel.
– For electronic dossiers, assign secure temporary access with audit trail.
– Record retrieval activity details in retrieval log.
– Return dossiers promptly following review or use, ensuring documentation is updated.
– Report and investigate any discrepancy or damage immediately.

4. In-Process Controls and Verification:
– Conduct periodic audits for physical and electronic storage conditions.
– Verify accuracy and completeness of archival and retrieval logs.
– Ensure compliance with retention timelines.
– Address deviations through CAPA as per quality system.

5. Acceptance Criteria:
– Complete dossier packages with valid approvals, signatures, and required documentation.
– Securely stored without damage or data loss.
– Traceability demonstrated through logs and tracking system.
– Retrieval performed timely with documented authorization.

6. Deviations and Approvals:
– Any deviation or missing documentation identified during archival or retrieval must be immediately reported.
– Obtain necessary approvals for exceptions.
– Document and route deviations for correction and prevention.

7. Documentation and Record Retention:
– Maintain all logs, request forms, and tracking records for the duration of dossier retention period.
– Ensure records are legible, accessible, and protected.
– Archive electronic backup copies as per IT policy.
– Dispose of dossiers only after authorized retention period and approval by Regulatory Affairs Head.

8. Closure:
– Confirm completion of archival or retrieval activity.
– Sign off on logs and update master records.
– Communicate status to relevant stakeholders as needed.

Abbreviations

RA – Regulatory Affairs
SOP – Standard Operating Procedure
CAPA – Corrective and Preventive Actions
GMP – Good Manufacturing Practice
PDF – Portable Document Format
IT – Information Technology

Documents

The following documents are essential for adherence and proper execution of this SOP:

1. Approved Dossier Archival Request Form (Annexure-1)
2. Dossier Retrieval Authorization Form (Annexure-2)
3. Archival and Retrieval Logbook (Annexure-3)

References

– EMA Guidelines on Good Regulatory Practice
– ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
– FDA 21 CFR Part 11: Electronic Records; Electronic Signatures
– Internal Quality Management System Documentation
– Company IT Security and Data Integrity Policies

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Approved Dossier Archival Request Form

Title	Approved Dossier Archival Request Form
Purpose	To formally request the archival of approved dossiers in compliance with regulatory and internal requirements.

Product Name	Product ABC
Dossier Type	Registration
Submission Number	SUB123456
Approval Date	10/03/2026
Requested By	Regulatory Affairs Executive
Date of Request	16/04/2026
Signature	_______________
Remarks	Complete dossier package ready for archival.

Annexure-2: Dossier Retrieval Authorization Form

Title	Dossier Retrieval Authorization Form
Purpose	To authorize retrieval of approved dossiers for regulatory, audit, or operational needs with proper traceability.

Product Name	Product ABC
Dossier Type	Registration
Submission Number	SUB123456
Requested By	QA Auditor
Date of Retrieval Request	20/04/2026
Authorization By	Regulatory Affairs Manager
Date of Authorization	21/04/2026
Signature	_______________
Purpose of Retrieval	Regulatory audit preparation
Remarks	Dossier required for 3 days.

Annexure-3: Archival and Retrieval Logbook

Title	Archival and Retrieval Logbook
Purpose	To maintain a record of all archival and retrieval transactions of approved dossiers for audit trail and compliance monitoring.

Date	Activity	Product Name	Dossier Type	Submission Number	Performed By	Remarks
16/04/2026	Archival	Product ABC	Registration	SUB123456	Regulatory Affairs Executive	Complete dossier archived
21/04/2026	Retrieval	Product ABC	Registration	SUB123456	QA Auditor	Retrieved for audit, returned 24/04/2026

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
16/04/2026	1.0	Initial issue	New SOP creation