Standard Operating Procedure for Response Strategy Meetings and Decision Logging
| Department | Regulatory Affairs |
| SOP No. | RA/2026/736 |
| 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 approach for conducting response strategy meetings and documenting decisions relating to health authority queries, deficiency letters, and other regulatory communications. The purpose of this SOP is to ensure timely, consistent, and compliant responses while facilitating cross-functional collaboration, enhancing communication clarity, and maintaining traceable records that support regulatory compliance and inspection readiness.
Scope
This SOP applies to all activities involving the planning, execution, and documentation of response strategy meetings for regulatory affairs related to health authority queries and deficiency letter management within the organization. It covers all product types, dosage forms, registrations, dossiers, and submissions overseen by the Regulatory Affairs department, including coordination with Quality Assurance, Quality Control, Manufacturing, and other relevant functions. Excluded are routine regulatory submissions not involving deficiency or query responses.
Responsibilities
The following roles are involved in this process:
- Regulatory Affairs Officer: Initiates and coordinates response strategy meetings, prepares agendas, and oversees documentation.
- Regulatory Affairs Manager: Reviews and approves response strategies and meeting outcomes.
- Quality Assurance Representative: Provides compliance input and ensures alignment with quality standards.
- Subject Matter Experts (e.g., Manufacturing, QC, R&D): Provide technical and operational input relevant to queries.
- Meeting Recorder/Coordinator: Documents meeting discussions, decisions, and action items.
- Compliance Officer: Monitors adherence to regulatory timelines and escalation requirements.
Accountability
The Regulatory Affairs Head holds accountability for ensuring this SOP is implemented effectively, remains compliant with applicable regulations, is reviewed periodically, and that any deviations or escalations from the response strategy process are managed promptly. This role ensures ongoing effectiveness through regular audits and training reinforcement.
Procedure
1. Preparation: Upon receipt of a health authority query or deficiency letter, the Regulatory Affairs Officer reviews the communication and notifies relevant stakeholders. A meeting is scheduled within an agreed timeline to align with regulatory response deadlines.
2. Pre-Meeting Activities: The Regulatory Affairs Officer prepares a preliminary analysis of the queries and circulates an agenda along with any supporting documents to invitees including QA, QC, Manufacturing, and other subject matter experts.
3. Conducting the Meeting: The meeting is led by the Regulatory Affairs Manager or designated facilitator. Discussions focus on understanding the queries, identifying root causes if applicable, and determining response strategies, including technical answers, corrective actions, or additional data requests.
4. In-Process Controls: Throughout the meeting, the recorder documents discussions accurately along with identified action items, owners, and agreed timelines. GMP compliance and regulatory guidelines are referenced to guide decision making.
5. Verification and Approval: Draft responses generated based on the meeting outcomes are reviewed by the Regulatory Affairs Manager and QA Representative for accuracy and compliance before submission.
6. Deviation Handling: Any unforeseen issues, inability to meet deadlines, or conflicting information identified during the process are promptly escalated to the Regulatory Affairs Head for resolution.
7. Documentation and Record Retention: Meeting minutes, response drafts, approval records, and correspondence are compiled, finalized, and stored in the regulatory document management system in accordance with document control procedures.
8. Closure: Upon submission of responses to the health authority, the Regulatory Affairs Officer confirms receipt acknowledgment if available, updates tracking systems, and schedules follow-up actions if required.
This structured approach assures that response strategies are unanimously agreed upon, accurately documented, timely executed, and compliant with applicable regulatory requirements, reducing risk of regulatory non-compliance and facilitating smooth health authority interactions.
Abbreviations
GMP: Good Manufacturing Practice
QA: Quality Assurance
QC: Quality Control
SOP: Standard Operating Procedure
RA: Regulatory Affairs
Documents
- Response Strategy Meeting Agenda Template (Annexure-1)
- Response Strategy Meeting Minutes Template (Annexure-2)
- Health Authority Query Response Tracking Log (Annexure-3)
References
1. WHO Technical Report Series – Good Regulatory Practices
2. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
3. EMA Guidelines on Handling of Regulatory Queries
4. Internal Quality Management System Documentation
5. GMP Annex 11 – Computerized Systems
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Response Strategy Meeting Agenda Template
| Document Title | Response Strategy Meeting Agenda |
| Purpose | To outline topics and schedule for the response strategy meeting to discuss regulatory queries and draft responses. |
| Meeting Date | Location | Meeting Facilitator | Minute Taker |
|---|---|---|---|
| 20/04/2026 | Virtual – MS Teams | Regulatory Affairs Manager | Regulatory Affairs Officer |
| Time | Agenda Item | Presenter |
|---|---|---|
| 10:00 – 10:10 | Opening and Introductions | Regulatory Affairs Manager |
| 10:10 – 10:30 | Review of Health Authority Query Content | Regulatory Affairs Officer |
| 10:30 – 11:00 | Discussion on Technical Issues and Root Cause Analysis | Subject Matter Experts |
| 11:00 – 11:30 | Proposed Response Strategies and Assignments | Regulatory Affairs Manager |
| 11:30 – 11:45 | Timeline and Follow-up Actions | Compliance Officer |
| 11:45 – 12:00 | Meeting Closure | Regulatory Affairs Manager |
Annexure-2: Response Strategy Meeting Minutes Template
| Document Title | Response Strategy Meeting Minutes |
| Purpose | To formally record discussions, decisions, action items, and responsibilities made during the response strategy meeting. |
| Meeting Date: | 20/04/2026 |
|---|---|
| Start Time: | 10:00 |
| End Time: | 12:00 |
| Location: | Virtual – MS Teams |
| Facilitator: | Regulatory Affairs Manager |
| Minute Taker: | Regulatory Affairs Officer |
Discussion Summary
The meeting began with introductions followed by a comprehensive review of the health authority query regarding the product manufacturing process. Subject matter experts presented the root cause analysis identifying documentation gaps. Proposed corrective actions included updated data submission and process adjustments. Assignments of responsible individuals for each action item were agreed upon, with deadlines aligned to regulatory response timelines.
Action Items
| Action Item | Responsible Person | Due Date | Status |
|---|---|---|---|
| Prepare draft response for query point 1 | Regulatory Affairs Officer | 27/04/2026 | Open |
| Verify manufacturing batch records | Manufacturing SME | 25/04/2026 | Open |
| Review draft response for compliance | QA Representative | 29/04/2026 | Pending |
| Submit final response to health authority | Regulatory Affairs Manager | 30/04/2026 | Pending |
Meeting Closure
The next meeting was scheduled contingent on response review progress. Meeting adjourned at 12:00.
Annexure-3: Health Authority Query Response Tracking Log
| Document Title | Health Authority Query Response Tracking Log |
| Purpose | To systematically track the receipt, analysis, drafting, review, submission, and closure of health authority queries and responses. |
| Query Reference No. | Receipt Date | Response Due Date | Status |
|---|---|---|---|
| HAQ-2026-015 | 15/04/2026 | 30/04/2026 | In Progress |
| Activity | Responsible | Completion Date | Remarks |
|---|---|---|---|
| Initial Review of Query | Regulatory Affairs Officer | 16/04/2026 | Completed |
| Response Strategy Meeting | Regulatory Affairs Manager | 20/04/2026 | Completed |
| Draft Response Preparation | Regulatory Affairs Officer | Pending | Due 27/04/2026 |
| Final Review & Approval | QA Representative | Pending | Due 29/04/2026 |
| Response Submission | Regulatory Affairs Manager | Pending | Target 30/04/2026 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |