Standard Operating Procedure for Tracking Open Regulatory Commitments and Actions
| Department | Regulatory Affairs |
| SOP No. | RA/2026/619 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 08/04/2026 |
| Effective Date | 08/04/2026 |
| Review Date | 08/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes a systematic approach for identifying, monitoring, and managing all open regulatory commitments and related actions to ensure timely compliance with applicable global regulatory requirements. It aims to maintain regulatory compliance and support audit readiness by providing controlled oversight on tracking, documenting, and closing regulatory obligations arising from submissions, inspections, approvals, and communications with regulatory authorities.
Scope
This SOP applies to all regulatory affairs operations involved in the management of open regulatory commitments linked to submissions, registrations, license renewals, inspections, and other regulatory correspondence across all product types, dosage forms, and geographic markets where the company operates. The scope includes commitments originating from regulatory authorities, health agencies, and internal stakeholders but excludes commitments related solely to commercial contractual obligations or non-regulatory business functions.
Responsibilities
The following roles are involved in the execution and maintenance of this SOP:
- Regulatory Affairs Associate/Coordinator: Responsible for recording and updating open commitments in the tracking system and preparing routine status reports.
- Regulatory Affairs Manager: Reviews tracker accuracy, oversees compliance with timelines, and escalates overdue or critical actions.
- Quality Assurance (QA): Performs periodic audits of commitments management process and associated documentation.
- Department Heads: Ensure resource availability and compliance within their functional areas to meet regulatory commitments.
- Document Control: Maintains controlled records of commitment-related documents and revision history.
Accountability
The Regulatory Affairs Head is accountable for the effective implementation, ongoing compliance, and periodic review of this SOP. This role is responsible for escalating any significant deviations or non-compliance issues and for assessing the overall effectiveness of the commitment tracking process on a scheduled basis.
Procedure
1. Preparation and Prerequisites:
1.1 Ensure access to the current regulatory commitments tracking system (electronic or physical log) with defined user roles and permissions.
1.2 Familiarize with all recent regulatory correspondences, approvals, inspection reports, and submissions that may contain commitments.
2. Identification and Recording:
2.1 Upon receipt of any regulatory communication involving commitments, immediately review and extract all actionable points.
2.2 Record each open commitment in the tracking log with a unique identifier, detailed description, source document reference, due date, responsible person, and status.
2.3 Classify commitments by priority and regulatory region to facilitate monitoring.
3. Monitoring and Execution:
3.1 Regulatory staff must regularly review the tracker for upcoming, due, or overdue commitments, at minimum weekly.
3.2 Responsible individuals execute required actions in compliance with applicable procedures, including preparation of submissions, validations, or corrective actions.
3.3 Maintain all supporting evidence, correspondence, and records demonstrating completion of each commitment.
4. Verification and Closure:
4.1 Upon completion, verify that the action meets the defined acceptance criteria and regulatory expectations.
4.2 Update the tracker status to “closed” and cross-reference closure evidence such as submission acknowledgments or inspection close-out letters.
4.3 If commitments are not met by the due date, follow the escalation procedure to notify management and regulatory authorities as necessary.
5. Reporting and Review:
5.1 Generate periodic reports summarizing active commitments, impending deadlines, and closed items for management review.
5.2 Conduct quarterly reviews of commitment tracking effectiveness and process adherence.
6. Document Retention:
6.1 Retain all commitment-related documentation as per company document control procedures and regulatory requirements.
7. Deviations and Change Control:
7.1 Document, investigate, and approve any deviations or changes affecting regulatory commitments management through the appropriate quality systems.
Abbreviations
RA – Regulatory Affairs
QA – Quality Assurance
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
Documents
The following documents are essential for managing open regulatory commitments and actions:
- Regulatory Commitments Tracking Log (Annexure-1)
- Regulatory Actions Status Report (Annexure-2)
- Commitment Closure Evidence Checklist (Annexure-3)
References
– ICH Q10 Pharmaceutical Quality System
– FDA Guidance for Industry: Postmarketing Reporting Commitments
– EU Guidelines on Good Regulatory Practices
– Company Document Control Policy
– Relevant Regional Regulatory Authority Requirements and Standards
Version
1.0
Approval
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| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Commitments Tracking Log
Purpose: To systematically capture and monitor all open regulatory commitments and related details.
| Commitment ID | Source Document | Regulatory Authority | Description of Commitment | Due Date | Responsible Person | Status | Comments |
|---|---|---|---|---|---|---|---|
| COM-2026-001 | Inspection Report IR-045/26 | FDA | Submit corrective action plan for facility inspection | 15/05/2026 | Regulatory Affairs Associate | Open | In progress |
| COM-2026-002 | Marketing Authorization Approval MA-322 | EMA | Provide updated stability data for Product X | 30/06/2026 | Regulatory Affairs Manager | Open | Data collection ongoing |
| COM-2025-150 | Post Approval Letter PAL-789 | MHRA | Submit revised product labeling per new guidelines | 28/04/2026 | Regulatory Specialist | Closed | Submitted on 26/04/2026 |
Annexure-2: Regulatory Actions Status Report
Purpose: To summarize the current status of all open and recently closed regulatory commitments for management review.
| Report Date | Total Open Commitments | Critical Overdue | On-Time Completions | Escalations Raised | Prepared By |
|---|---|---|---|---|---|
| 01/04/2026 | 5 | 1 | 12 | 0 | Regulatory Affairs Coordinator |
| 15/03/2026 | 7 | 0 | 10 | 1 | Regulatory Affairs Coordinator |
Annexure-3: Commitment Closure Evidence Checklist
Purpose: To ensure all required documentation and evidence are collected and verified before formally closing a regulatory commitment.
| Commitment ID | Evidence Type | Document Reference | Verification Date | Verifier Signature | Comments |
|---|---|---|---|---|---|
| COM-2025-150 | Submission Acknowledgment | Letter No. PAL-789 | 26/04/2026 | __________ | Verified submission compliance |
| COM-2024-102 | Inspection Close-out Letter | Letter No. IR-099 | 12/02/2025 | __________ | Confirmed inspection closure |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 08/04/2026 | 1.0 | Initial issue | New SOP creation |