SOP for Regulatory Governance Meetings and Decision Tracking


Regulatory Affairs: SOP for Regulatory Governance Meetings and Decision Tracking – V 1.0

Standard Operating Procedure for Regulatory Governance Meetings and Decision Tracking

Department Regulatory Affairs
SOP No. RA/2026/784
Supersedes NA
Page No. 1 of X
Issue Date 17/04/2026
Effective Date 17/04/2026
Review Date 17/04/2028

Purpose

This Standard Operating Procedure (SOP) establishes a structured approach for conducting regulatory governance meetings and systematically tracking decisions made within regulatory affairs. The objective is to ensure effective cross-functional coordination, timely compliance with regulatory requirements, and consistent documentation of meeting outcomes to support transparent decision-making and regulatory governance processes.

Scope

This SOP applies to all regulatory governance meetings involving regulatory affairs and cross-functional teams, including but not limited to meetings related to submission planning, compliance evaluations, document review, and regulatory strategy discussions. It covers the processes for scheduling, conducting, recording, reviewing, and following up on decisions made during these meetings. This SOP is relevant to all products, dosage forms, regulatory submissions, and internal governance activities under the regulatory affairs department. Excluded are non-regulatory meetings and operational meetings outside regulatory governance scope.

Responsibilities

The following roles are involved in the execution and oversight of this SOP:

  • Regulatory Affairs Coordinator: Organizes meetings, prepares agendas, and documents meeting minutes.
  • Regulatory Affairs Manager: Facilitates meetings, ensures adherence to the agenda, and reviews decision tracking documentation.
  • Cross-Functional Representatives: Participate in discussions, provide input, and assist in decision-making.
  • Quality Assurance: Reviews governance meeting outputs for compliance with quality and regulatory standards.
  • Document Control: Maintains and archives meeting records and decision logs as per retention policy.
See also  SOP for Regulatory Department Work Allocation and Escalation

Accountability

The Regulatory Affairs Head is accountable for ensuring the implementation, ongoing compliance, periodic review, and effectiveness of this SOP. They will escalate unresolved issues, approve updates, and ensure that documented decisions are implemented within regulatory and organizational requirements.

Procedure

1. Preparation and Planning

The Regulatory Affairs Coordinator shall schedule governance meetings based on regulatory timelines and organizational needs. Prior to each meeting, an agenda will be prepared and circulated to all participants at least 3 working days in advance. Relevant documentation, such as regulatory submissions, previous meeting minutes, and decision logs, must be distributed with the agenda.

2. Meeting Prerequisites

Participants must review all pre-circulated documents to come prepared for discussions. The meeting venue or virtual platform should be arranged beforehand, ensuring required technical facilities and confidentiality compliance.

3. Conduct of Meeting

The Regulatory Affairs Manager will open the meeting, confirm the agenda, and ensure that discussions follow the planned topics. All attendees are encouraged to participate, providing updates and input relevant to regulatory governance.

The meeting minutes shall be recorded by the Regulatory Affairs Coordinator, capturing key discussions, decisions made, responsible persons, and timelines for action items.

4. In-Process Controls and Verification

Decisions and action items logged during meetings shall be reviewed by the Regulatory Affairs Manager for clarity and feasibility. Any conflicting issues or required escalations must be identified and addressed promptly.

5. Approval and Documentation

Draft meeting minutes shall be circulated to all attendees within 2 working days for review and comments. Finalized minutes, incorporating agreed amendments, must be approved by the Regulatory Affairs Manager and archived per document control procedures.

6. Distribution and Record Retention

Final meeting minutes and decision tracking logs will be distributed to all relevant stakeholders. Records shall be retained securely for a minimum of 5 years or as per company retention policy, ensuring controlled access and confidentiality.

See also  SOP for Annual Review and Revision of Regulatory SOPs

7. Follow-Up and Closure

The Regulatory Affairs Coordinator shall monitor completion of assigned action items and update decision logs accordingly. Escalations for any delays or issues shall be reported to the Regulatory Affairs Head. Completed actions will be formally closed in subsequent meetings.

8. Handling Deviations

Any deviations from the SOP in meeting conduct, decision documentation, or follow-up must be documented and reported to Quality Assurance. Corrective actions will be implemented promptly to restore compliance.

9. Training and Awareness

All involved personnel shall receive training on this SOP during onboarding and at least annually thereafter to maintain awareness of procedures and responsibilities.

Abbreviations

RA – Regulatory Affairs
SOP – Standard Operating Procedure
QA – Quality Assurance
GMP – Good Manufacturing Practice
IT – Information Technology

Documents

  1. Regulatory Governance Meeting Agenda Template (Annexure-1)
  2. Regulatory Governance Meeting Minutes and Decision Log (Annexure-2)
  3. Action Items Follow-Up Checklist (Annexure-3)

References

EU GMP Annex 11 – Computerized Systems, ICH Q10 Pharmaceutical Quality System, FDA 21 CFR Part 11 Compliance Guidelines, Company Quality Management System Manual, Internal Document Control Policy.

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Regulatory Governance Meeting Agenda Template

Purpose: To provide a standardized format for planning and communicating the agenda items for regulatory governance meetings.

Meeting ID RG-2026-04-001
Date 20/04/2026
Time 10:00 AM – 12:00 PM
Location / Platform Conference Room 3 / MS Teams
Prepared By
Agenda Items
  1. Review of previous meeting minutes
  2. Regulatory submission updates and timelines
  3. Compliance audit findings and corrective actions
  4. Cross-functional regulatory strategy discussion
  5. Decision tracking and action item review
Participants Regulatory Affairs, QA, QC, Manufacturing, Documentation Control

Annexure-2: Regulatory Governance Meeting Minutes and Decision Log

Purpose: To document discussions, decisions, responsible persons, and deadlines arising from regulatory governance meetings.

Meeting ID RG-2026-04-001
Date 20/04/2026
Minutes Prepared By
Agenda Item Discussion Summary Decision Made Responsible Person Target Date
Regulatory submission updates Status of pending submissions reviewed; challenges impacting timelines noted. Prioritize submission for XYZ product; allocate additional resources. Regulatory Affairs Coordinator 05/05/2026
Compliance audit findings Discussed recent audit gaps in documentation control. Implement additional training sessions and review procedures. QA Manager 15/05/2026
See also  SOP for Tracking Open Regulatory Commitments and Actions

Annexure-3: Action Items Follow-Up Checklist

Purpose: To track completion status of action items resulting from regulatory governance meetings and ensure timely closure.

Action Item Description Assigned To Due Date Completion Status Remarks
1 Submit documentation update for XYZ product Regulatory Affairs Coordinator 05/05/2026 Pending On track; in progress
2 Conduct compliance training session QA Manager 15/05/2026 Pending Training scheduled

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
17/04/2026 1.0 Initial issue New SOP creation

Related Guidelines: