Standard Operating Procedure for Coordination Between Regulatory QA CMC and Clinical Teams

Department	Regulatory Affairs
SOP No.	RA/2026/786
Supersedes	NA
Page No.	1 of X
Issue Date	17/04/2026
Effective Date	17/04/2026
Review Date	17/04/2028

Purpose

This SOP defines the standardized process for effective coordination between Regulatory Quality Assurance (QA) Chemistry, Manufacturing, and Controls (CMC) teams and Clinical teams. It aims to ensure seamless communication, accurate data exchange, compliance with regulatory requirements, and timely execution of cross-functional responsibilities to support product development and regulatory submission activities.

Scope

This SOP applies to all personnel involved in Regulatory QA CMC and Clinical functions across all therapeutic areas and product dosage forms. It covers coordination tasks relating to documentation, data review, action tracking, training, compliance verification, and submission management. Activities outside of regulatory and clinical coordination such as raw data generation or clinical trial conduct are excluded.

Responsibilities

• Regulatory QA CMC Team: Preparation, review, and sharing of CMC documentation and regulatory data.
• Clinical Team: Provision of clinical data inputs, protocol coordination, and adherence to regulatory requirements.
• Regulatory Affairs Coordinator: Facilitate communication, organize meetings, and monitor cross-functional deliverables.
• Quality Assurance Representative: Oversee compliance of coordination practices with GMP and regulatory standards.
• Document Control Specialist: Ensure controlled documentation exchange and version management.

Accountability

The Head of Regulatory Affairs is accountable for ensuring implementation, ongoing compliance, periodic review, escalation of deviations, and assessment of the effectiveness of this SOP.

Procedure

1. Preparation and Prerequisites: Identify and establish the core contact points within the Regulatory QA CMC and Clinical teams. Confirm that all involved personnel have received requisite training on this SOP and regulatory requirements relevant to workflows. Ensure controlled access to shared documentation platforms.

2. Coordination Planning: Develop a coordination schedule outlining regular meetings, review cycles, data exchange timelines, and escalation paths. Establish agendas aligning with regulatory submission milestones and clinical development timelines.

3. Communication and Data Exchange: Facilitate information sharing through secure, documented means such as emails, electronic document management systems, and formal meeting minutes. Ensure that all shared data, including protocols, reports, and regulatory documents, are reviewed and approved by respective departments prior to dissemination.

4. In-Process Controls and Monitoring: Maintain logs of actions, queries, and responses arising during coordination activities. Monitor adherence to schedules and follow up on pending items. Perform periodic audits of coordination records to verify compliance and identify improvement opportunities.

5. Handling Deviations: Should deviations in coordination activities or timelines occur, document the nature, root cause, and corrective actions taken. Escalate issues to the Head of Regulatory Affairs as needed. Ensure transparency and traceability of all corrective measures.

6. Documentation and Record Keeping: Archive all coordination-related documentation, including meeting minutes, correspondence, training records, and action logs, in designated controlled repositories. Adhere to retention timelines aligned with regulatory and company policies.

7. Review and Continuous Improvement: Conduct annual reviews of coordination effectiveness, gathering feedback from involved teams. Update this SOP and coordination procedures based on regulatory updates, audit findings, and process improvements.

Abbreviations

• CMC – Chemistry, Manufacturing, and Controls
• QA – Quality Assurance
• SOP – Standard Operating Procedure
• GMP – Good Manufacturing Practice
• RA – Regulatory Affairs

Documents

All documents listed are integral to ensuring effective coordination and compliance:

1. Coordination Meeting Agenda and Minutes Template (Annexure-1)
2. Cross-Functional Action Item Log (Annexure-2)
3. Training and Attendance Record for Coordination Activities (Annexure-3)

References

International Council for Harmonisation (ICH) Guidelines, FDA and EMA Regulatory Guidance on CMC and Clinical Data Integration, Good Manufacturing Practice (GMP) requirements, Internal Quality Management System Policies, and Document Control Procedures.

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Coordination Meeting Agenda and Minutes Template

Purpose: To document the agenda and minutes of coordination meetings between Regulatory QA CMC and Clinical teams to ensure clear communication and tracking of action items.

Meeting Date	15/04/2026
Meeting Time	10:00 AM – 11:00 AM
Attendees	Regulatory QA CMC Lead, Clinical Project Manager, RA Coordinator, QA Representative
Agenda Items	Review of current submission timelines Discussion on clinical data updates Identification of gaps in documentation Action item allocation and deadlines
Minutes	Submission timelines validated and confirmed. Clinical data discrepancies flagged for resolution. Documentation gaps assigned to respective teams. Next meeting scheduled for 29/04/2026.
Prepared By
Approved By

Annexure-2: Cross-Functional Action Item Log

Purpose: To track and monitor action items assigned during coordination activities ensuring timely completion and accountability.

Action Item	Responsible Department	Assigned To	Due Date	Status	Comments
Resolve clinical data discrepancies	Clinical	Clinical Data Coordinator	22/04/2026	In Progress	Awaiting updated reports
Update CMC documentation to fill gaps	Regulatory QA CMC	CMC Documentation Specialist	25/04/2026	Pending	To start after data reconciliation

Annexure-3: Training and Attendance Record for Coordination Activities

Purpose: To maintain a record of personnel trained on coordination procedures and participation in related training sessions to ensure competency and compliance.

Training Date	Training Topic	Attendee Role	Attendee Department	Trainer	Signature
10/04/2026	Coordination SOP Overview	Regulatory QA CMC Lead	Regulatory Affairs	Qualified Trainer
10/04/2026	Coordination SOP Overview	Clinical Project Manager	Clinical	Qualified Trainer

Revision History

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