Standard Operating Procedure for Health Authority Query Receipt Logging and Triage
| Department | Regulatory Affairs |
| SOP No. | RA/2026/724 |
| 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) establishes a consistent and controlled approach for the receipt, logging, categorization, and triage of health authority queries. The purpose is to ensure timely, accurate, and systematic handling of regulatory correspondence, supporting compliance with applicable regulatory requirements and facilitating effective regulatory response management throughout the product lifecycle.
Scope
This SOP applies to all health authority queries received by the Regulatory Affairs department relating to any functional area, product type, dosage form, and regulatory submission or approval stage. It covers the processes for logging incoming queries, assessment of query nature and urgency, allocation to appropriate functional experts, and preparation for response development. Activities outside health authority query management, such as internal deviations or non-regulatory correspondence, are excluded.
Responsibilities
- Regulatory Affairs Officers: Responsible for receiving, logging, initial assessment, and triage of queries.
- Functional Subject Matter Experts: Provide technical input and prepare responses as per received queries.
- Regulatory Affairs Manager: Reviews and approves query classification, prioritization, and response timelines.
- Quality Assurance: Verifies compliance with regulatory requirements and documentation standards.
- Documentation Control: Ensures proper archiving and retrieval of query correspondence and response records.
Accountability
The Head of Regulatory Affairs holds primary accountability for implementing and maintaining this SOP. This role is accountable for ensuring compliance, conducting periodic reviews and updates of the procedure, escalating issues when required, and monitoring effectiveness to align with regulatory obligations and company policies.
Procedure
The following procedure outlines the stepwise approach for health authority query receipt logging and triage:
1. Receipt and Initial Verification
Upon receipt of a query via email, courier, or online portal, Regulatory Affairs Officers verify completeness of the correspondence and date-stamp the physical or electronic copy. If incomplete or ambiguous, attempt to obtain clarifications from the sender or escalate as per escalation matrix.
2. Logging of Query
Enter query details into the Health Authority Query Log, capturing date received, query origin, reference number, subject matter, and brief summary. Assign a unique query identification number for tracking.
3. Classification and Prioritization
Assess the nature of the query—whether scientific, regulatory procedural, compliance-related, or other. Prioritize based on specified timelines from the health authority or internal standards (e.g., urgent safety questions receive expedited handling).
4. Assignment to Functional Experts
Allocate the query to the appropriate regulatory or technical functional expert for detailed evaluation and response drafting. Communicate expected timelines and provide all relevant documentation.
5. Tracking and Monitoring
Regularly monitor query status within the tracking system, ensuring response milestones are met. Flag delays or bottlenecks for management intervention.
6. Documentation and Record Keeping
Maintain an electronic and/or physical file containing the query, all related correspondence, assessment notes, response drafts, approvals, and final submission evidence. Comply with document retention policies.
7. Closure
Upon submission of the response to the health authority, update the log with closure date and outcome notes. Conduct a brief review to identify any process improvement opportunities.
Safety and Compliance Checks: Prior to release, ensure all responses are reviewed for accuracy, regulatory compliance, and alignment with internal quality standards. Ensure confidentiality and data integrity throughout the process.
Deviation Handling: Any deviations from defined timelines or procedures are to be documented and escalated per deviation management protocols.
This procedure enables controlled management of health authority queries, thereby supporting compliance, traceability, and timely regulatory communication.
Abbreviations
- RA: Regulatory Affairs
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practices
- HAC: Health Authority Correspondence
Documents
The following documents are required and directly related to the management of health authority queries:
- Health Authority Query Log (Annexure-1)
- Health Authority Query Triage Checklist (Annexure-2)
- Health Authority Response Tracking Worksheet (Annexure-3)
References
- ICH Q10 Pharmaceutical Quality System
- FDA Guidance for Industry: Responses to Premarket Approval Applications and Supplements
- EU GMP Guide – Chapter 1: Quality Management
- Company Quality Manual and Document Control Procedures
- Applicable local and international regulatory authority guidelines
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Health Authority Query Log
Purpose: To maintain a comprehensive record of all health authority queries received for tracking, prioritization, and audit purposes.
| Query ID | Date Received | Health Authority | Reference No. | Subject | Priority | Assigned To | Status | Closure Date |
|---|---|---|---|---|---|---|---|---|
| HAQ-2026-001 | 10/04/2026 | FDA | FDA-REF-5632 | Stability Data Query | High | Regulatory Officer A | In Progress | – |
| HAQ-2026-002 | 12/04/2026 | EMA | EMA-REF-9874 | Labeling Clarification | Medium | Regulatory Officer B | Closed | 14/04/2026 |
Annexure-2: Health Authority Query Triage Checklist
Purpose: To guide initial assessment and prioritization of incoming health authority queries ensuring consistent triage decisions.
| Date of Receipt | 12/04/2026 |
| Query Origin | European Medicines Agency (EMA) |
| Reference Number | EMA-REF-9874 |
| Query Type | Labeling / Artwork Clarification |
| Urgency Level | Medium (Response due within 10 working days) |
| Assigned Department / Functional Expert | Regulatory Affairs – Labeling Specialist |
| Additional Comments / Instructions | Coordinate with Quality Assurance for label validation |
| Triage Checker (Signature) | ______________________ |
| Date | 12/04/2026 |
Annexure-3: Health Authority Response Tracking Worksheet
Purpose: To monitor progress and status of response preparation, review, approval, and submission for each health authority query.
| Query ID | Assigned To | Response Draft Completion Date | Review Completion Date | Management Approval Date | Submission Date | Compliance Status |
|---|---|---|---|---|---|---|
| HAQ-2026-001 | Regulatory Officer A | 13/04/2026 | 13/04/2026 | 14/04/2026 | 14/04/2026 | Compliant |
| HAQ-2026-002 | Regulatory Officer B | 13/04/2026 | 13/04/2026 | 13/04/2026 | 14/04/2026 | Compliant |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 14/04/2026 | 1.0 | Initial issue | New SOP creation |