Standard Operating Procedure for Internal Review and Approval of Regulatory Deliverables

Department	Regulatory Affairs
SOP No.	RA/2026/617
Supersedes	NA
Page No.	1 of X
Issue Date	08/04/2026
Effective Date	08/04/2026
Review Date	08/04/2028

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a clear, consistent, and controlled process for the internal review and approval of regulatory deliverables before submission or implementation. This SOP ensures that all regulatory documents meet applicable quality, compliance, and regulatory standards to maintain regulatory integrity, reduce errors, and uphold timely and accurate submission requirements.

Scope

This SOP applies to all regulatory deliverables generated within the Regulatory Affairs department, including but not limited to regulatory submissions, registration dossiers, briefing documents, product labels, risk assessments, and correspondence with regulatory authorities. The procedure is relevant to documents related to any functional area or dosage form within the organization. Activities excluded are deliverables under clinical trial management and marketing materials review processes unless specifically linked to regulatory submissions.

Responsibilities

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

• Regulatory Affairs Reviewer – responsible for initial document review for accuracy, compliance, and completeness.
• Regulatory Affairs Supervisor – oversees review process and approves deliverables prior to final approval.
• Quality Assurance – provides independent verification, audit readiness review, and compliance oversight.
• Document Control – manages document version control, archiving, and maintains audit trails.
• Regulatory Affairs Head – supervises and ensures adherence to SOP throughout the process.

Accountability

The Regulatory Affairs Head is accountable for the effective implementation, compliance, and periodic review of this SOP. This role is responsible for escalation of issues, ensuring timely completion of review cycles, and assessment of SOP effectiveness during management reviews.

Procedure

1. Preparation and Prerequisites:

Before initiating the review process, ensure the regulatory deliverable is complete and compiled according to applicable templates and regulatory requirements. Confirm that all supporting data and references are included. Verify that the document version is controlled and each page is numbered.

2. Initial Review:

The Regulatory Affairs Reviewer verifies the deliverable for technical accuracy, completeness, format compliance, and alignment with applicable regulations. This includes checking cross-references, tables, and critical statements for consistency. Any comments or required corrections are documented and communicated to the document originator.

3. Incorporation of Feedback:

The originator addresses review comments as applicable and submits the revised deliverable for re-evaluation. The Reviewer verifies that all comments are appropriately resolved and no new issues have been introduced.

4. Supervisory Review and Approval:

After successful review by the Regulatory Affairs Reviewer, the Regulatory Affairs Supervisor performs a secondary review focusing on conformity with organizational policy and strategic objectives. Upon satisfaction, the Supervisor approves the deliverable for final Quality Assurance (QA) review.

5. Quality Assurance Verification:

QA conducts an independent compliance check, focusing on regulatory adherence, documentation standards, and audit readiness. QA may request further clarifications or corrections before providing the final approval recommendation.

6. Final Approval and Release:

Upon satisfactory review by all parties, the Regulatory Affairs Head gives the final approval. The approved deliverable is then uploaded to the document management system with appropriate version control metadata.

7. Documentation and Record Retention:

All review records, including review comments, approvals, and revision histories, must be retained within the controlled documentation system in accordance with company retention policies. Records must be accessible for audits and inspections.

8. Deviation and Escalation:

Any deviations from the review process must be documented and reported immediately to the Regulatory Affairs Head. Corrective actions should be implemented as appropriate. Significant issues affecting submission timelines must be escalated promptly.

This procedure ensures a controlled, documented, and traceable review and approval process that maintains the integrity and quality of regulatory deliverables across all regulatory functions.

Abbreviations

QA – Quality Assurance

RA – Regulatory Affairs

SOP – Standard Operating Procedure

GMP – Good Manufacturing Practice

CTD – Common Technical Document

Documents

The following documents are required specifically for the internal review and approval of regulatory deliverables:

1. Regulatory Deliverable Review Form (Annexure-1)
2. Review Comments Log (Annexure-2)
3. Approval Sign-Off Sheet (Annexure-3)

References

• ICH Q10 Pharmaceutical Quality System

• FDA Guidance for Industry: Submission Documentation

• EMA Guideline on the Content, Management and Archiving of the Dossier

• Company Document Control Policy

• Good Documentation Practice (GDP) guidelines

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Regulatory Deliverable Review Form

Purpose: To document the detailed review of a regulatory deliverable including verification of content, accuracy, regulatory compliance, and format prior to approval.

Document Title:	Example Submission Dossier
Version:	1.2
Reviewer Name:
Review Date:	10/04/2026
Checklist of Review Items:	Content completeness: Yes Regulatory references accurate: Yes Formatting compliant: Yes Cross-references validated: Yes Significant concerns identified: No
Comments:	No discrepancies found; document is ready for supervisory review.
Signature of Reviewer:	______________________

Annexure-2: Review Comments Log

Purpose: To record all reviewer comments and observations along with responses and resolution status during the internal review process.

Comment No.	Section/Page	Reviewer Comment	Response/Action Taken	Status
1	Section 3.2, page 15	Clarify reference to stability data source	Added stability report reference in footnote	Closed
2	Table 5, page 22	Formatting inconsistent with CTD guidelines	Reformatted table according to CTD specifications	Closed

Annexure-3: Approval Sign-Off Sheet

Purpose: To formally record the approval of the regulatory deliverable by the designated authorized personnel before release or submission.

Role	Name	Signature	Date
Regulatory Affairs Reviewer		______________________	12/04/2026
Regulatory Affairs Supervisor		______________________	13/04/2026
Quality Assurance		______________________	14/04/2026
Regulatory Affairs Head (Final Approval)		______________________	15/04/2026

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
08/04/2026	1.0	Initial issue	New SOP creation