Standard Operating Procedure for Documentation of Regulatory Commitments From Agency Queries
| Department | Regulatory Affairs |
| SOP No. | RA/2026/741 |
| 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 consistent and controlled process for documenting all regulatory commitments arising from queries issued by health authorities. It aims to ensure thorough, timely, and auditable recording of commitments made during regulatory interactions, supporting compliance with applicable regulatory requirements and enabling effective tracking of commitment fulfillment within the pharmaceutical quality system.
Scope
This SOP applies to all regulatory affairs personnel handling agency queries and all functional departments involved in providing inputs or executing activities related to regulatory commitments. It covers all product types, dosage forms, processes, and related documentation systems associated with regulatory submissions and communications. Activities such as commitment logging, verification, follow-up, and closure are included. This SOP does not cover internal quality or manufacturing commitments not related to regulatory agency correspondences.
Responsibilities
- Regulatory Affairs Team: Receive, review, and document agency queries and commitments, and coordinate responses.
- Functional Area Representatives: Provide timely and accurate information or actions needed to meet commitments.
- Quality Assurance: Review and monitor compliance with commitments and the documentation process.
- Document Control: Maintain controlled versions of commitment documentation and related records.
- Management: Support resources for compliance and provide oversight where applicable.
Accountability
The Head of Regulatory Affairs is accountable for implementing this SOP, ensuring adherence by involved personnel, reviewing the effectiveness of the process, and escalating unresolved issues. This role also ensures periodic reviews and updates of the SOP according to changes in regulations or internal requirements.
Procedure
1. Receipt and Initial Review of Agency Queries: Upon receipt of a query or deficiency letter from a regulatory authority, Regulatory Affairs shall log the communication in the dedicated Regulatory Query Log with details such as date received, reference number, and sender details.
2. Analysis and Determination of Commitments: Regulatory Affairs together with relevant functional representatives shall review each query to identify required commitments, deduce timelines, and assess impact on ongoing regulatory submissions or product availability.
3. Documentation of Commitments: All commitments made in response to queries shall be clearly recorded in the Regulatory Commitments Register. Each record will include a unique commitment ID, description of commitment, responsible department(s), due dates, and any conditions applied by the regulatory authority.
4. Communication and Acknowledgment: Regulatory Affairs shall ensure formal communication of commitments and timelines to internal stakeholders for action. Confirmation of acceptance, if applicable, is documented and retained.
5. Implementation and Monitoring: Responsible departments shall execute agreed commitments within agreed timelines, documenting relevant activities and evidences as per internal control procedures. Regulatory Affairs periodically reviews progress and status during internal meetings.
6. Verification and Closure: Upon completion of the commitment, verification is conducted to confirm fulfillment against the regulatory expectations. A closure note including evidential documents shall be prepared, reviewed by QA, and appended to the commitment record.
7. Deviation Handling: Any delays or challenges in fulfilling commitments must be reported immediately to Regulatory Affairs and QA. Deviations must be documented, investigated, and corrective actions implemented to mitigate regulatory risks.
8. Record Retention and Archiving: All documentation related to regulatory commitments shall be retained in accordance with the company’s document retention policy, ensuring easy retrieval for audits or inspections.
9. Periodic Review: The Regulatory Affairs management shall conduct periodic reviews of outstanding commitments to ensure timely closure and address systemic issues if trends of non-compliance are observed.
This procedure ensures all regulatory commitments arising from agency queries are proactively managed with transparency and controlled documentation supporting ongoing compliance and regulatory trust.
Abbreviations
- QA – Quality Assurance
- RA – Regulatory Affairs
- SOP – Standard Operating Procedure
- GMP – Good Manufacturing Practice
- API – Active Pharmaceutical Ingredient
- CAPA – Corrective and Preventive Action
Documents
Documents specifically required for managing regulatory commitments and their documentation include:
- Regulatory Query Log (Annexure-1)
- Regulatory Commitments Register (Annexure-2)
- Commitment Closure and Verification Form (Annexure-3)
References
- EMA Guidelines on Good Regulatory Practice
- FDA Guidance for Industry – Regulatory Submissions
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Internal Quality Management System Manuals
- Pharmaceutical Documentation and Record Keeping Standards
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Query Log
| Field | Description / Example |
|---|---|
| Log ID | RQL-2026-001 |
| Date Received | 10/04/2026 |
| Agency Name | European Medicines Agency (EMA) |
| Query Reference Number | EMA/RA/5678 |
| Product Name | Product X Immediate Release Tablets |
| Query Summary | Request for stability data clarification on batch 12345 |
| Received By | Regulatory Affairs Department |
| Initial Review Date | 11/04/2026 |
| Comments | Forwarded to Quality Control for data review |
Annexure-2: Regulatory Commitments Register
| Field | Description / Example |
|---|---|
| Commitment ID | RC-2026-045 |
| Related Query Log ID | RQL-2026-001 |
| Commitment Description | Provide additional stability data for batch 12345 by 30/06/2026 |
| Responsible Department | Quality Control |
| Due Date | 30/06/2026 |
| Status | In Progress |
| Last Update | 01/05/2026 |
| Comments | Data collection ongoing |
Annexure-3: Commitment Closure and Verification Form
| Field | Description / Example |
|---|---|
| Commitment ID | RC-2026-045 |
| Date of Completion | 25/06/2026 |
| Verification Performed By | QA Department |
| Verification Date | 27/06/2026 |
| Verification Comments | Additional stability data reviewed and accepted |
| Closure Approval | Approved for closure |
| Remarks | Commitment fulfilled within timeline |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |