Standard Operating Procedure for Follow-Up Management After Submission of Responses

Department	Regulatory Affairs
SOP No.	RA/2026/734
Supersedes	NA
Page No.	1 of X
Issue Date	14/04/2026
Effective Date	14/04/2026
Review Date	14/04/2028

Purpose

This Standard Operating Procedure (SOP) defines the systematic process for managing follow-up activities after submission of responses to health authority queries, deficiency letters, or other regulatory communications. It ensures timely tracking, monitoring, escalation, and closure of submitted responses and supports compliance with regulatory timelines and quality standards. This SOP aims to maintain effective communication with regulatory bodies and uphold the integrity and transparency of the submission and follow-up process.

Scope

This SOP applies to all regulatory affairs activities involving the preparation, submission, and follow-up of responses to health authority queries, deficiency letters, or requests for information related to product dossiers, manufacturing processes, validation studies, quality control data, laboratory findings, and other regulatory documentation. It covers all pharmaceutical dosage forms, functional departments involved in response generation, and relevant documentation systems. Activities outside regulatory submission follow-up, such as initial response drafting or unrelated correspondence, are excluded.

Responsibilities

The following functional roles are involved:

• Regulatory Affairs Officer: Responsible for tracking health authority communications, coordinating response submission, and initiating follow-up activities.
• Regulatory Affairs Manager: Supervises follow-up management, reviews correspondence status, and directs escalation if required.
• Quality Assurance (QA): Reviews and approves final responses and follow-up reports.
• Document Control: Maintains archiving of correspondence and follow-up records.
• Cross-functional Teams (Manufacturing, QC, Validation, etc.): Provide necessary data or clarifications for follow-up as required.

Accountability

The Head of Regulatory Affairs holds overall accountability for the implementation, compliance, regular review, and continuous improvement of this SOP. This role ensures timely escalation of issues, periodic effectiveness assessment, and alignment with corporate and regulatory requirements.

Procedure

1. Preparation and Prerequisites: Upon receipt of a health authority communication, the Regulatory Affairs Officer records the query or deficiency letter in the designated tracking system. Confirm completeness of the response package and verify submission acknowledgement receipt.

2. Follow-Up Planning: Define follow-up timelines based on regulatory timelines, internal standard timelines, or specific commitments made during submissions. Establish reminders and escalation points within the tracking system.

3. Monitoring Follow-Up Status: Monitor health authority portals, emails, or correspondence regularly for updates on the submitted responses. Cross-check acknowledgements or requests for additional information. Update status logs promptly.

4. Escalation Procedure: If no reply or acknowledgement is received within predefined timelines, initiate follow-up emails or phone calls to the health authority contact points. Document all communications and outcomes. Escalate internally to the Regulatory Affairs Manager as required for further action.

5. In-Process Controls: Confirm all follow-up activities adhere to GMP and data integrity requirements. Ensure traceability of communication and actions taken. Validate that responses meet regulatory expectations and quality standards.

6. Verification and Documentation: Compile evidence of submission and follow-up activities, including copies of communications, acknowledgements, and status reports. Review and approve all follow-up documentation by QA before final archiving.

7. Acceptance Criteria: Follow-up is considered complete when formal acknowledgement of response acceptance is received, or the regulatory body formally closes the query. In case of additional requests, the loop of follow-up continues until satisfactory closure.

8. Deviations and Corrective Actions: Document any delays, communication gaps, or unexpected issues as deviations. Investigate root causes and implement corrective and preventive actions to prevent recurrence.

9. Record Retention and Closure: All follow-up records shall be retained according to regulatory record-keeping requirements. Upon closure of queries, update the master tracking log and communicate the closure status to stakeholders.

This procedure supports continuity, regulatory compliance, and audit readiness for all follow-up activities after submitting responses.

Abbreviations

GMP: Good Manufacturing Practice
QA: Quality Assurance
QC: Quality Control
SOP: Standard Operating Procedure
RA: Regulatory Affairs

Documents

The following documents are essential to this SOP:

1. Health Authority Query Response Tracking Log (Annexure-1)
2. Follow-Up Communication Record Form (Annexure-2)
3. Deviation Report Form for Follow-Up Activities (Annexure-3)

References

1. ICH Q7 Good Manufacturing Practice Guide
2. EU Guidelines on Good Manufacturing Practice for Medicinal Products
3. FDA Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants
4. EMA Guideline on the Format and Content of Dossiers and Regulatory Communications
5. Internal Quality Management System Documentation and Records Policy

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Health Authority Query Response Tracking Log

Purpose: To systematically record and monitor all queries received from health authorities along with the status of submitted responses and follow-up activities.

Query ID	Date Received	Health Authority	Subject	Response Submission Date	Acknowledgement Received	Current Status
HAQ-2026-001	01/03/2026	FDA	Deficiency on Stability Data	10/03/2026	Yes – 12/03/2026	Closed
HAQ-2026-002	05/03/2026	EMA	Validation Protocol Clarifications	15/03/2026	Pending	Follow-Up In Progress
HAQ-2026-003	20/03/2026	PMDA	Manufacturing Process Query	30/03/2026	Yes – 02/04/2026	Closed

Annexure-2: Follow-Up Communication Record Form

Purpose: To document all follow-up communications with health authorities regarding submitted responses to ensure traceability and compliance.

Date	Query ID	Mode of Follow-Up	Contact Person / Department	Summary of Communication	Next Action	Handled By
22/03/2026	HAQ-2026-002	Email	EMA Regulatory Affairs	Requested update on review status of submitted validation clarifications.	Wait for response within 5 working days.	Regulatory Affairs Officer
30/03/2026	HAQ-2026-002	Phone Call	EMA Regulatory Affairs	Followed-up due to no update; informed under review and response expected shortly.	Monitor response daily.	Regulatory Affairs Officer
05/04/2026	HAQ-2026-002	Email	EMA Regulatory Affairs	Received confirmation of request closure.	Update tracking log to closed status.	Regulatory Affairs Officer

Annexure-3: Deviation Report Form for Follow-Up Activities

Purpose: To report and document deviations encountered during follow-up management, including delays, communication lapses, or procedural non-compliances.

Deviation No.	Date	Query ID	Description of Deviation	Root Cause	Corrective Actions	Preventive Actions	Status	Reported By	Reviewed By	Approved By
DEV-2026-005	28/03/2026	HAQ-2026-002	Delayed follow-up beyond established timeline due to internal resource constraints.	Insufficient staffing in regulatory affairs during reporting period.	Reallocate resources and prioritize follow-up activities.	Enhance resource planning and cross-training of staff.	Closed	Regulatory Affairs Officer	Quality Assurance	Head Regulatory Affairs

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
14/04/2026	1.0	Initial issue	New SOP creation