Standard Operating Procedure for Health Authority Correspondence Logging and Follow-Up
| Department | Regulatory Affairs |
| SOP No. | RA/2026/608 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 07/04/2026 |
| Effective Date | 07/04/2026 |
| Review Date | 07/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes a systematic and controlled process for the receipt, logging, tracking, and timely follow-up of all health authority correspondence. It ensures effective management and regulatory compliance with applicable guidelines by providing a robust mechanism for documentation, response monitoring, and closure of communications with regulatory bodies. The SOP aims to maintain audit readiness and promote accountability within the Regulatory Affairs function.
Scope
This SOP applies to all incoming and outgoing correspondence with health authorities received by the Regulatory Affairs department, including but not limited to letters, emails, notifications, queries, and acknowledgments related to regulatory submissions, approvals, inspections, and post-approval commitments. It covers all product dosage forms, regulatory processes, and documentation systems within the organization. Correspondence unrelated to health authority communications or managed by other departments is excluded.
Responsibilities
- Regulatory Affairs Executive/Officer: Receiving, logging, initial assessment, and routing of correspondence.
- Regulatory Affairs Manager/Supervisor: Review and monitoring of follow-up status; escalation of pending issues.
- Quality Assurance: Providing oversight on compliance with applicable regulations and internal controls.
- Document Control: Maintaining master files and archival of correspondence records.
- Appropriate Functional Departments: Providing inputs and responses to regulatory queries as assigned.
Accountability
The Head of Regulatory Affairs is accountable for ensuring effective implementation, ongoing compliance, timely review, escalation of issues, and periodic evaluation of the SOP’s effectiveness. This role is also responsible for recommending updates and ensuring training of personnel involved in health authority correspondence management.
Procedure
The following steps define the process for managing health authority correspondence effectively within the regulatory framework:
1. Receipt and Identification: Any incoming communication from health authorities must be received centrally by the Regulatory Affairs department. All correspondence should be date-stamped, scanned, and physically handed over or electronically forwarded immediately upon receipt.
2. Logging: The Regulatory Affairs Executive shall log the correspondence into the Health Authority Correspondence Log Register (see Annexure-1) capturing essential details such as date received, sender’s details, subject, reference number, assigned responsible person, and response due date.
3. Initial Review and Assignment: The content of the correspondence must be reviewed promptly to assess the nature and urgency. Based on this, the correspondence shall be assigned to the appropriate functional area or individual for action.
4. Follow-Up Planning: The assigned person must prepare an action plan outlining the response requirements, timelines, necessary approvals, and documentation.
5. Execution and Response Preparation: Compilation of required data, cross-functional collaboration, and drafting of the response must be conducted adhering to GMP and regulatory compliance standards. Draft responses should undergo internal review before approval.
6. Review and Approval: The Regulatory Affairs Manager or designated approver must review and authorize the response for submission.
7. Submission and Confirmation: The approved response shall be submitted to the health authority using a traceable method, ensuring receipts or acknowledgments are obtained and filed.
8. Documentation and Record Retention: All correspondence, logs, response drafts, approvals, and submission evidence shall be maintained in the master regulatory records as per documentation control procedures.
9. Monitoring and Escalation: The Regulatory Affairs Manager shall monitor timelines and pending actions. If delays or deviations occur, immediate escalation is required. Deviations must be documented and addressed per quality management procedures.
10. Closure: Once a final reply or resolution is obtained, the correspondence entry must be updated to indicate closure and retained for audit purposes.
This process shall be continuously reviewed for effectiveness and compliance with applicable regulatory guidelines and internal policies.
Abbreviations
- GMP: Good Manufacturing Practice
- SOP: Standard Operating Procedure
- RA: Regulatory Affairs
- QA: Quality Assurance
- HA: Health Authority
Documents
The following documents are essential for the proper execution and control of health authority correspondence management:
- Health Authority Correspondence Log Register (Annexure-1)
- Health Authority Correspondence Response Template (Annexure-2)
- Health Authority Correspondence Follow-Up Checklist (Annexure-3)
References
- ICH Q10: Pharmaceutical Quality System
- FDA Guidance on Regulatory Submissions and Communications
- EMA Guideline on Good Pharmacovigilance Practices (GVP)
- 21 CFR Part 11 for Electronic Records and Signatures
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Internal Document Control and Data Retention Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Health Authority Correspondence Log Register
| Log ID | Date Received | Sender/Health Authority | Subject | Reference No. | Assigned To | Response Due Date | Status |
|---|---|---|---|---|---|---|---|
| HA-2026-001 | 05/04/2026 | FDA | Request for Additional Stability Data | FDA-RA-12345 | Quality Control | 19/04/2026 | Open |
| HA-2026-002 | 06/04/2026 | EMA | Submission Acknowledgement | EMA-SUB-56789 | Regulatory Affairs | N/A | Closed |
Annexure-2: Health Authority Correspondence Response Template
| To: [Health Authority Name] |
| From: Regulatory Affairs Department |
| Subject: Response to Correspondence Ref. No. [Reference Number] |
| Date: [DD/MM/YYYY] |
| Dear Sir/Madam, |
|
In reference to your correspondence dated [Date of Health Authority Letter], regarding [Subject], please find below our response and supporting information:
|
| Please contact us for any further clarification. |
| Sincerely, |
| Regulatory Affairs Team |
Annexure-3: Health Authority Correspondence Follow-Up Checklist
| Checklist Item | Completed (Yes/No) | Comments |
|---|---|---|
| Correspondence received and date-stamped | Yes | 05/04/2026 |
| Logged into correspondence register | Yes | Log ID HA-2026-001 |
| Assigned responsible department/person | Yes | Quality Control |
| Response due date established | Yes | 19/04/2026 |
| Response drafted and internally reviewed | No | In progress |
| Approval obtained for response | No | Pending |
| Response submitted and acknowledgement received | No | N/A |
| File updated and correspondence closed | No | N/A |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 07/04/2026 | 1.0 | Initial issue | New SOP creation |