Standard Operating Procedure for Query Tracker Maintenance and Closure Verification
| Department | Regulatory Affairs |
| SOP No. | RA/2026/737 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 15/04/2026 |
| Effective Date | 15/04/2026 |
| Review Date | 15/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes a systematic process for maintaining a comprehensive query tracker and verifying the closure of queries related to regulatory affairs activities. The SOP ensures timely monitoring, management, and documentation of health authority queries, deficiency letters, and related communications to support regulatory compliance, enhance response accuracy, and maintain transparency during submission and approval workflows.
Scope
This SOP applies to all regulatory affairs personnel involved in managing health authority queries and deficiency letters related to product registrations, submissions, and regulatory correspondence. It encompasses the maintenance of query tracking tools, verification of query closure status, interdepartmental coordination, and recordkeeping. The SOP excludes activities not related to regulatory query management, such as internal audit management or quality investigations.
Responsibilities
- Regulatory Affairs Executives – responsible for recording, updating, and monitoring queries in the tracker.
- Regulatory Affairs Supervisors – responsible for reviewing tracker updates and ensuring timely query closure.
- Documentation Control – responsible for maintaining query response records and archiving related communications.
- Regulatory Affairs Manager – responsible for oversight, review, and escalation of delayed or complex queries.
- Quality Assurance – responsible for periodic audit and verification of query tracker accuracy and completeness.
Accountability
The Regulatory Affairs Head is accountable for the implementation, compliance, periodic review, and effectiveness of this SOP. The role is also responsible for escalating unresolved or high-risk queries and ensuring adherence to regulatory timelines and quality standards.
Procedure
The query tracker maintenance and closure verification process is conducted through the following steps:
1. Preparation and Prerequisites: Ensure the availability and accessibility of the latest query tracker template, approved communication templates, and reference documents such as submission dossiers and regulatory guidelines. Verify user access permissions for the tracker tool.
2. Recording Incoming Queries: Upon receipt of health authority communications (queries, deficiency letters), regulatory personnel shall log each query detail in the tracker within 24 hours. Record fields include query reference number, date received, related submission or product details, query description, responsible person, and initial status.
3. Assignment and Prioritization: Assign the query to the relevant stakeholder or department responsible for drafting the response based on the subject matter. Prioritize queries according to regulatory deadlines, complexity, and risk impact.
4. Tracking Response Development: Monitor progress on response preparation, ensuring that drafts comply with regulatory and company standards. Conduct intra- and interdepartmental reviews and approvals as per internal workflow.
5. Verification of Query Closure: Upon submission of the query response to the health authority, update the tracker with submission date and reference details. Confirm query closure status by verifying official acknowledgement or closure communication from the authority. Document any outstanding or follow-up requirements.
6. Monitoring and Escalation: Conduct weekly reviews of open queries, identify delayed responses, and escalate these to the Regulatory Affairs Manager for corrective actions. Track trends or recurring issues for continuous improvement.
7. Documentation and Record Retention: Maintain all query-related correspondence, attachments, and tracker copies in the regulatory documentation system. Ensure records are accurate, legible, and stored to comply with regulatory and company retention policies.
8. Reporting and Review: Prepare periodic status reports summarizing query volumes, response times, and closure rates for management review. Incorporate findings into training or process enhancement initiatives.
9. Deviation and Corrective Actions: Document and manage any deviations from this SOP or query handling timelines through the established CAPA process. Implement corrective actions to prevent recurrence.
10. Continuous Improvement: Regularly update the query tracker format, workflows, and training materials to align with evolving regulatory requirements and company practices.
Abbreviations
- SOP – Standard Operating Procedure
- CAPA – Corrective and Preventive Actions
- RA – Regulatory Affairs
- QA – Quality Assurance
- GMP – Good Manufacturing Practice
- HT – Health Authority Queries Tracker
Documents
The documents required for effective execution of this SOP are:
- Health Authority Query Tracker Template (Annexure-1)
- Query Response Closure Form (Annexure-2)
- Weekly Query Status Report Format (Annexure-3)
References
- ICH Q10 Pharmaceutical Quality System
- EU Guidelines on Good Pharmacovigilance Practices
- FDA Guidance for Industry on Regulatory Submissions
- Company Document Control and Record Retention Policy
- Applicable National Regulatory Authority Regulations
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Health Authority Query Tracker Template
| Query Ref. No. | Date Received | Product/Submission | Query Description | Assigned To | Priority | Status | Response Submission Date | Closure Date |
|---|---|---|---|---|---|---|---|---|
| HAQ-2026-001 | 01/04/2026 | Product A – NDA Submission | Labeling discrepancies noted | Regulatory Affairs Team | High | Closed | 10/04/2026 | 12/04/2026 |
| HAQ-2026-002 | 05/04/2026 | Product B – ANDA Submission | CMC section clarification requested | CMC Team | Medium | Open | – | – |
Annexure-2: Query Response Closure Form
| Query Reference Number | HAQ-2026-001 |
| Date Response Submitted | 10/04/2026 |
| Submitted By (Dept.) | Regulatory Affairs |
| Closure Date | 12/04/2026 |
| Health Authority Acknowledgement Reference | HA-Ltr-8923 |
| Remarks | Query satisfactorily resolved and closed by authority. |
| Verified By | Regulatory Affairs Supervisor |
| Date | 13/04/2026 |
Annexure-3: Weekly Query Status Report Format
| Week Ending | Total Queries Open | Total Queries Closed | Overdue Queries | Escalations | Remarks |
|---|---|---|---|---|---|
| 15/04/2026 | 5 | 12 | 1 | 1 | On track overall; follow-up on overdue query ongoing. |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |