Standard Operating Procedure for Post-Dispatch Submission Reconciliation

Department	Regulatory Affairs
SOP No.	RA/2026/703
Supersedes	NA
Page No.	1 of X
Issue Date	13/04/2026
Effective Date	13/04/2026
Review Date	13/04/2028

Purpose

This SOP establishes the standardized process for post-dispatch submission reconciliation to ensure that all regulatory submissions dispatched are accurately recorded, verified, and accounted for. It supports the control objective of maintaining traceability, completeness, and compliance of regulatory submissions to meet internal quality standards and external regulatory requirements.

Scope

This procedure applies to all regulatory affairs personnel involved in preparing, reviewing, dispatching, and verifying electronic Common Technical Document (eCTD) and other regulatory submissions post-dispatch. It covers the reconciliation of submission records, dispatch logs, confirmation receipts, and related documentation for all product types and submission categories dispatched from the organization. It excludes submissions handled by external agencies beyond the initial dispatch confirmation.

Responsibilities

• Regulatory Affairs Coordinator: Execute submission record reconciliation and maintain dispatch logs.
• Quality Assurance Reviewer: Review reconciliation records and oversee compliance with the SOP.
• Regulatory Affairs Manager: Supervise the process and address discrepancies or deviations.
• Document Control: Archive reconciled submission records and related documents appropriately.

Accountability

The Regulatory Affairs Head is accountable for ensuring the implementation, adherence, periodic review, and effectiveness of this SOP. This role is responsible for escalation of unresolved discrepancies and for facilitating any corrective actions required as a result of the reconciliation process.

Procedure

1. Preparation and Prerequisites:

Ensure all dispatch records, submission packages, and confirmation receipts are available and complete. Verify that submission dates and identifiers correspond between the dispatch logs and submission master files. Confirm access to the relevant electronic submission tracking systems or databases.

2. Safety and GMP Checks:

Confirm that submissions are controlled as per documented procedures and handled with confidentiality and document integrity. Verify that all documents adhere to quality standards before the reconciliation process begins.

3. Execution Steps:

a. Retrieve Dispatch Records: Collect the dispatch logs and submission tracking sheets for the period under review.

b. Verify Submission Details: Cross-check each dispatched submission against the dispatch record to confirm submission ID, date, recipient details, and content completeness.

c. Confirm Receipt Acknowledgment: Where applicable, obtain and verify receipt acknowledgements from regulatory authorities or agencies.

d. Document Discrepancies: Record any missing, delayed, or inconsistent submission details for investigation and resolution.

4. In-Process Controls and Verification:

Conduct periodic spot checks during reconciliation to ensure accuracy. Use electronic audit trails for submission records to validate dispatch events. Confirm that all reconciled data is consistent with original submission documentation.

5. Acceptance Criteria:

All dispatched submissions must be accounted for with corresponding confirmation or receipt records. Any discrepancies must be resolved within defined timelines, with corrective actions documented and approved.

6. Handling Deviations:

Report any reconciliation discrepancies to the Regulatory Affairs Manager immediately. Initiate corrective and preventive actions (CAPA) as necessary, ensure investigation records are maintained, and update reconciliation records accordingly.

7. Approvals and Documentation:

Prepare a reconciliation summary report and submit it for review and approval by Quality Assurance. Ensure final approved records are formally archived in controlled document management systems.

8. Record Retention and Closure:

Retain all reconciliation records, summary reports, CAPA documentation, and approval evidence in accordance with regulatory and company retention policies. Confirm closure of reconciliation cycle by documented approval and notify relevant departments.

Abbreviations

• eCTD – electronic Common Technical Document
• QA – Quality Assurance
• CAPA – Corrective and Preventive Actions
• SOP – Standard Operating Procedure

Documents

1. Post-Dispatch Submission Reconciliation Log (Annexure-1)
2. Dispatch Confirmation Receipt Template (Annexure-2)
3. Submission Discrepancy Report Form (Annexure-3)

References

• ICH M2 eCTD Specifications
• FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Post-Submission Issues
• Internal Document Control Policy
• Good Documentation Practices (GDP) Guidelines
• ISO 9001:2015 Quality Management Systems Requirements

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Post-Dispatch Submission Reconciliation Log

Purpose: To document and verify the reconciliation of dispatched regulatory submissions with records and receipts.

Submission ID	Product/Device	Dispatch Date	Recipient Agency	Receipt Confirmation (Y/N)	Remarks
SUB-2026-001	Product A	05/04/2026	FDA	Y	Confirmed receipt via email
SUB-2026-002	Product B	06/04/2026	EMA	Y	Receipt dated 07/04/2026
SUB-2026-003	Product C	07/04/2026	MHRA	N	Follow-up pending

Annexure-2: Dispatch Confirmation Receipt Template

Purpose: To confirm receipt of dispatched regulatory submissions by the receiving agency.

Submission ID:
Dispatch Date:
Received By:
Receipt Date:
Comments:
Signature:
Date:

Annexure-3: Submission Discrepancy Report Form

Purpose: To record details of discrepancies found during the post-dispatch submission reconciliation process.

Submission ID:	SUB-2026-003
Date of Reconciliation:	13/04/2026
Discrepancy Description:	Receipt confirmation not received from MHRA.
Action Taken:	Follow-up initiated; awaiting response.
Reported By:
Reviewed By:
Approved By:
Date:

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
13/04/2026	1.0	Initial issue	New SOP creation