Standard Operating Procedure for Regulatory Operations Review Meetings and Action Tracking
| Department | Regulatory Affairs |
| SOP No. | RA/2026/613 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 07/04/2026 |
| Effective Date | 07/04/2026 |
| Review Date | 07/04/2028 |
Purpose
This Standard Operating Procedure (SOP) defines the structured process for conducting regulatory operations review meetings and systematic tracking of associated actions. It ensures consistent oversight, timely decision-making, and documented follow-up on regulatory activities to maintain compliance with applicable regulatory requirements, promote transparency, and support continuous improvement within the regulatory affairs function.
Scope
This SOP applies to all regulatory operations review meetings conducted within the Regulatory Affairs department encompassing regulatory submissions, compliance monitoring, documentation control, and related activities across all regulated products and dosage forms. It covers planning, execution, documentation, and action tracking phases and excludes meetings conducted outside the regulatory function or unrelated to regulatory operations.
Responsibilities
The following roles are responsible for the execution and oversight of this SOP:
- Regulatory Affairs Manager – Oversees meeting adherence to agenda and controls review quality.
- Regulatory Operations Coordinator – Schedules meetings, prepares agendas, and manages documentation.
- Quality Assurance Representative – Provides compliance perspective during reviews and action assessment.
- Regulatory Team Members – Participate in meetings, provide inputs, and execute assigned actions.
- Document Control Personnel – Ensure proper filing and retention of meeting records and action logs.
Accountability
The Regulatory Affairs Head is accountable for the effective implementation, compliance monitoring, periodic review, escalation of issues, and ensuring the overall effectiveness of this SOP. This role is responsible for ensuring corrective actions arising from review meetings are completed on time and documented appropriately.
Procedure
1. Preparation and Scheduling: The Regulatory Operations Coordinator shall schedule the regulatory operations review meetings at predetermined intervals or as needed, ensuring availability of all relevant stakeholders. An agenda outlining key points and topics for discussion must be prepared and distributed to participants at least three business days in advance.
2. Prerequisites and Documentation: All participants must review relevant documents, including regulatory submissions status reports, compliance metrics, previous meeting minutes, and open action logs prior to the meeting to facilitate informed discussion.
3. Conducting the Meeting: The Regulatory Affairs Manager shall lead the meeting, ensuring that agenda items are covered comprehensively. Discussions should focus on the status of regulatory submissions, compliance issues, deviations, inspection readiness, documentation updates, and any pending regulatory inquiries.
4. Action Identification and Assignment: During the meeting, all required actions shall be clearly identified, documented with specific details including action owner, description, due date, and priority level. The Regulatory Operations Coordinator shall compile these actions into a formal action log.
5. Verification and Documentation: Minutes of the meeting, including attendance, key discussions, decisions, and the assigned action log, must be drafted immediately after the meeting and reviewed by the Regulatory Affairs Manager. Upon approval, these documents shall be distributed to all participants and relevant stakeholders within two business days.
6. Follow-up and Tracking: The Regulatory Operations Coordinator is responsible for tracking all open actions, sending periodic reminders to action owners, and escalating overdue actions to the Regulatory Affairs Head. Progress on actions shall be reviewed in subsequent meetings until closure.
7. Record Retention: All meeting minutes, agendas, presentations, and action logs shall be filed in the designated regulatory documentation system with controlled access per departmental procedures. Records shall be retained for a minimum of five years or as per regulatory requirements.
8. Handling Deviations and Escalations: Any deviations from timelines or quality expectations identified during reviews shall be documented and corrective/preventive actions initiated as per the applicable change control or CAPA procedures. Escalations relating to significant compliance risks must be raised immediately to senior management.
This structured approach ensures regulatory operations meetings contribute effectively to compliance management, documentation integrity, and timely execution of regulatory obligations, safeguarding regulatory readiness and organizational audit preparedness.
Abbreviations
- CAPA: Corrective and Preventive Action
- GMP: Good Manufacturing Practices
- SOP: Standard Operating Procedure
- RA: Regulatory Affairs
- QA: Quality Assurance
Documents
- Regulatory Operations Review Meeting Agenda Template (Annexure-1)
- Regulatory Operations Review Meeting Minutes and Action Log (Annexure-2)
- Action Item Follow-Up Report (Annexure-3)
References
– ICH Q10 Pharmaceutical Quality System
– FDA Guidance for Industry: Good Review Management Principles and Practices
– EMA Guideline on Good Pharmacovigilance Practices (GVP)
– Internal Quality Management System Procedures
– Applicable Regulatory Agency Documentation Control Regulations
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Regulatory Operations Review Meeting Agenda Template
Purpose: To provide a standardized format for scheduling and organizing topics for regulatory operations review meetings to facilitate effective and structured discussions.
| Meeting Date | 07/04/2026 |
|---|---|
| Time | 10:00 AM – 12:00 PM |
| Location | Conference Room 3 / Virtual |
| Meeting Chairperson | Regulatory Affairs Manager |
| Attendees | Regulatory Team Members, QA Representative, Document Control |
Agenda Items:
- Review of previous meeting minutes and action status
- Update on regulatory submissions and approvals
- Compliance monitoring and deviations
- Inspection readiness status
- Documentation and record management updates
- New regulatory guidance or requirements
- Discussion on current regulatory challenges
- Identification and assignment of new action items
- Any other business
- Schedule next review meeting
Annexure-2: Regulatory Operations Review Meeting Minutes and Action Log
Purpose: To document the discussions, decisions, and assigned actions from regulatory operations review meetings to ensure traceability and follow-up compliance.
| Date | 07/04/2026 |
|---|---|
| Time | 10:00 AM – 12:00 PM |
| Location | Conference Room 3 / Virtual |
| Chairperson | Regulatory Affairs Manager |
| Recorded By | Regulatory Operations Coordinator |
Minutes Summary:
- Reviewed previous action status; two actions remained open with updated timelines.
- Discussed current regulatory submission timelines; all on track.
- Compliance deviations for batch record documentation addressed; CAPA initiated.
- Inspection readiness preparations progressing as planned.
- Updated documentation procedures approved.
- No new regulatory guidances received this period.
Action Log:
| Action No. | Description | Owner | Due Date | Status |
|---|---|---|---|---|
| 001 | Complete CAPA for batch documentation deviations | Regulatory Compliance Officer | 21/04/2026 | Open |
| 002 | Update registration dossier per new guidance | Regulatory Documentation Specialist | 30/04/2026 | Open |
Annexure-3: Action Item Follow-Up Report
Purpose: To monitor the progress and closure status of all action items assigned during regulatory operations review meetings, supporting timely completion and accountability.
| Action No. | Description | Owner | Original Due Date | Current Status | Remarks |
|---|---|---|---|---|---|
| 001 | Complete CAPA for batch documentation deviations | Regulatory Compliance Officer | 21/04/2026 | In Progress | Draft CAPA report under review |
| 002 | Update registration dossier per new guidance | Regulatory Documentation Specialist | 30/04/2026 | Pending | Awaiting draft annotations |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 07/04/2026 | 1.0 | Initial issue | New SOP creation |