Standard Operating Procedure for Drafting Reviewing and Approving Regulatory Responses
| Department | Regulatory Affairs |
| SOP No. | RA/2026/727 |
| 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, compliant, and controlled process for drafting, reviewing, and approving responses to regulatory queries, deficiency letters, and other communications issued by health authorities. It ensures timely, accurate, and effective communication while maintaining regulatory compliance, quality documentation standards, and alignment with organizational policies.
Scope
This SOP applies to all regulatory affairs personnel involved in managing, drafting, reviewing, and approving responses to health authority queries and deficiency letters related to products, processes, validations, equipment, documentation, and compliance activities across all functional areas and dosage forms within the organization. It covers interactions with national and international regulatory bodies and is applicable to all response submissions. Exclusions include internal audit reports and non-regulatory correspondence.
Responsibilities
The following roles are involved in this SOP:
- Regulatory Affairs Associate/Executive: Drafts initial responses based on received queries and relevant data.
- Subject Matter Experts (SMEs): Provide technical input and review content for accuracy.
- Regulatory Affairs Reviewer: Reviews response for compliance with regulatory requirements and company policies.
- Quality Assurance: Conducts final review to ensure adherence to GMP and documentation standards.
- Regulatory Affairs Head/Manager: Approves the final response prior to submission.
- Document Control: Ensures proper documentation and archiving of all records related to the responses.
Accountability
The Head of Regulatory Affairs holds overall accountability for the implementation, compliance, monitoring, and periodic review of this SOP. This includes escalation of non-conformities, ensuring training effectiveness, and approving necessary updates to maintain alignment with regulatory requirements and organizational standards.
Procedure
1. Receipt and Logging of Regulatory Queries
Upon receipt of a regulatory query or deficiency letter, the Regulatory Affairs Executive shall document the communication in the regulatory query tracking system, including receipt date, query reference, and deadline for response. The document control team shall file the official correspondence.
2. Preliminary Assessment and Assignment
The Regulatory Affairs Manager assigns the query to the appropriate SME(s) based on subject matter expertise, product, or system involved. Initial assessment includes clarifying any ambiguities and determining the technical, quality, or compliance inputs required.
3. Drafting of Response
The assigned Regulatory Affairs Executive collaborates with SMEs to compile accurate, complete, and scientifically justified responses. The draft must address each point raised by the authority clearly and concisely, referencing supporting documentation such as validation reports, batch records, or technical protocols.
4. Internal Review
The draft response undergoes a first review by the Regulatory Affairs Reviewer focusing on regulatory compliance, clarity, and completeness. Subsequently, QA reviews the draft to verify adherence to GMP principles, internal policies, and document control procedures.
5. Approval Process
The finalized response draft is submitted to the Head of Regulatory Affairs or delegated authority for approval. Any required amendments identified during approval are addressed promptly by the drafting team.
6. Submission
Upon approval, the response is formally submitted to the health authority within the stipulated timeline. Submission details including date, method, and acknowledgment receipt are recorded in the tracking system.
7. Documentation and Record Retention
All response drafts, review comments, approvals, and final submitted copies are archived in accordance with document retention policies. Associated reference documents and correspondence must be indexed and readily retrievable.
8. Monitoring and Follow-up
The Regulatory Affairs team monitors any further communication or feedback from the authority. In case of deviations or delays, escalation procedures are initiated as per compliance protocols.
9. Training
All personnel involved shall receive appropriate training on this SOP and related regulatory requirements to ensure competency and compliance.
10. Deviations and Amendments
Any deviation from this procedure must be documented, investigated, and approved by the Head of Regulatory Affairs. Amendments to responses post-submission shall follow regulatory guidance and internal approval processes.
Abbreviations
GMP: Good Manufacturing Practice
QA: Quality Assurance
SME: Subject Matter Expert
RA: Regulatory Affairs
Documents
The following documents are required for managing the drafting, reviewing, and approving of regulatory responses:
- Regulatory Query and Response Log (Annexure-1)
- Regulatory Response Draft Template (Annexure-2)
- Regulatory Response Approval Form (Annexure-3)
References
ICH Q7 Good Manufacturing Practice Guide
FDA Guidance for Industry – Responding to Deficiency Letters
EU GMP Guidelines Part I and Annexes
Company Quality Manual and Document Control Procedures
Applicable International Regulatory Authority Communication Guidelines
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Query and Response Log
Purpose: To record and track all regulatory queries and corresponding responses including key dates, responsible personnel, submission status, and follow-up actions.
| Query Reference | Receipt Date | Deadline Date | Assigned To | Response Submission Date | Status |
|---|---|---|---|---|---|
| HAQ-2026-0012 | 01/04/2026 | 15/04/2026 | Regulatory Affairs Executive | 14/04/2026 | Submitted |
| HAQ-2026-0013 | 05/04/2026 | 20/04/2026 | Regulatory Affairs Executive | 19/04/2026 | Submitted |
Annexure-2: Regulatory Response Draft Template
Purpose: To provide a standardized template for preparing clear and comprehensive responses to regulatory queries.
| Query Reference: HAQ-2026-0012 |
| Date: 14/04/2026 |
| Response Prepared By: Regulatory Affairs Executive |
| Response Details: |
|
1. Point 1: Explanation of the observed deviation and corrective measures implemented referencing Validation Report VR-2025-089. 2. Point 2: Summary of batch analysis data and confirmation of compliance with established specifications. 3. Point 3: Updated documentation control process and training records attached as supporting documents. |
| Supporting Documents: Validation Report VR-2025-089, Batch Analysis Report BAR-2025-112, Training Records TR-2026-005 |
Annexure-3: Regulatory Response Approval Form
Purpose: To document authorized approval of regulatory responses prior to submission.
| Response ID | Query Reference | Approved By | Approval Date | Comments |
|---|---|---|---|---|
| RESP-2026-0154 | HAQ-2026-0012 | Head of Regulatory Affairs | 14/04/2026 | Approved as per SOP requirements |
| RESP-2026-0155 | HAQ-2026-0013 | Head of Regulatory Affairs | 19/04/2026 | Approved with minor editorial corrections |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 14/04/2026 | 1.0 | Initial issue | New SOP creation |