Standard Operating Procedure for Query Response Quality Check Before Submission
| Department | Regulatory Affairs |
| SOP No. | RA/2026/730 |
| 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 controlled and consistent process for conducting quality checks on query responses prepared for submission to health authorities. The aim is to ensure all responses are accurate, complete, compliant with regulatory requirements, and aligned with company standards prior to official submission. This SOP supports the overarching control objective of maintaining regulatory compliance, enhancing submission quality, mitigating risk of rejection, and facilitating effective communication with authorities.
Scope
This SOP applies to all Regulatory Affairs personnel involved in preparing, reviewing, and finalizing responses to queries, deficiency letters, or requests from health authorities related to any product, dosage form, or process under the company’s regulatory submissions portfolio. It covers all types of query responses including but not limited to clinical, quality, manufacturing, and facility-related questions. This SOP excludes activities related to initial submission preparation and post-submission correspondence not classified as queries.
Responsibilities
- Regulatory Affairs Executive: Preparation of draft query responses as per assigned queries.
- Regulatory Affairs Reviewer: Review of draft responses for technical accuracy, completeness, and compliance.
- Quality Assurance (QA) Representative: Oversight of quality check execution and documentation compliance.
- Regulatory Affairs Manager: Approval of final query responses prior to submission.
- Documentation Control: Proper archival and record maintenance of query responses and quality check records.
Accountability
The Regulatory Affairs Head is accountable for the implementation, compliance monitoring, periodic review, escalation of issues, and ensuring the ongoing effectiveness of this SOP within the Regulatory Affairs department.
Procedure
The following procedure outlines the step-by-step approach for quality checking query responses before submission:
1. Preparation and Receipt of Query Response Draft: Regulatory Affairs Executive prepares the draft response addressing each health authority query point comprehensively. All supportive evidence and references must be included, formatted according to regulatory guidelines.
2. Prerequisites and Document Control Checks: Verify that the draft response version is identified clearly with date and version number. Confirm all relevant files, attachments, and supporting documents are prepared and linked.
3. Initial Quality Check by Regulatory Affairs Reviewer: Carry out a detailed review focusing on adherence to regulatory requirements, scientific accuracy, completeness of response, and consistency with the dossier and company position. Check for typographical errors, formatting consistency, and appropriate cross-references.
4. Compliance Verification: QA Representative reviews the response to ensure alignment with company SOPs, regulatory guidelines, and applicable standards such as ICH, GMP, and local regulations. Verify that any changes or clarifications made during review are documented with rationale.
5. Clarifications and Corrections: If discrepancies or gaps are detected, the draft is sent back to the Regulatory Affairs Executive with documented comments for corrections. Updated versions undergo repeat quality checks.
6. Final Approval: Upon satisfactory completion of quality checks, the Regulatory Affairs Manager reviews and approves the final query response package for submission.
7. Documentation and Record Retention: All reviewed drafts, comments, approvals, and supporting documents are systematically archived in the regulatory submission tracking system as per company document control practices and regulatory record retention requirements.
8. Closure and Escalation: Completion of the quality check process is documented. Any unresolved issues or significant deviations are escalated to the Regulatory Affairs Head for timely resolution. Feedback and lessons learned are incorporated for continual improvement.
This procedure ensures a robust quality control mechanism is in place, reducing risk of non-compliance, ensuring traceability, and supporting regulatory submission success.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practices
- ICH: International Council for Harmonisation
- RA: Regulatory Affairs
Documents
The following documents are essential tools and records for this SOP:
- Query Response Quality Check Checklist (Annexure-1)
- Query Response Review Comments Log (Annexure-2)
- Final Query Response Approval Form (Annexure-3)
References
- EU GMP Guidelines Part I & IV
- ICH Q9 – Quality Risk Management
- Local Health Authority Guidelines on Query Responses
- Internal Document Control and Regulatory Submission SOPs
- Company Quality Management System Manual
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Query Response Quality Check Checklist
| Checklist Item | Status | Comments |
|---|---|---|
| All query points addressed completely | Yes | – |
| References to supporting documents included | Yes | Verified Annexures attached |
| Formatting and numbering consistent | Yes | Standard template used |
| Technical accuracy checked | Yes | Cross-verified with dossier |
| Compliance with regulatory requirements confirmed | Yes | Reviewed against ICH guidelines |
| Typographical and grammatical errors corrected | No | Minor typo corrected in section 3 |
| Final draft ready for managerial approval | Yes | – |
Annexure-2: Query Response Review Comments Log
| Comment No. | Section | Comment | Action Taken | Date |
|---|---|---|---|---|
| 1 | Section 2.1 | Clarify assay method details | Expanded method description added | 10/04/2026 |
| 2 | Section 4 | Correct typographical error | Typo fixed and rechecked | 11/04/2026 |
| 3 | General | Include updated stability data reference | Referenced latest report Annexure 5 | 12/04/2026 |
Annexure-3: Final Query Response Approval Form
| Query ID: | HAQ-2026-045 |
| Response Version: | v1.2 |
| Date Submitted for Approval: | 13/04/2026 |
| Reviewed By (Regulatory Affairs Reviewer): | [Signature & Date] |
| Quality Assurance Checked By: | [Signature & Date] |
| Approved By (Regulatory Affairs Manager): | [Signature & Date] |
| Comments/Conditions: | No conditions, approved for submission |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 14/04/2026 | 1.0 | Initial issue | New SOP creation |