Standard Operating Procedure for Regulatory Process Compliance Checks

Department	Regulatory Affairs
SOP No.	RA/2026/621
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) defines the systematic approach and controls necessary for conducting compliance checks on regulatory processes. It ensures adherence to applicable regulatory requirements, internal policies, and quality standards, maintaining the integrity, accuracy, and completeness of regulatory submissions and documentation. The SOP supports the control objective of consistent regulatory compliance, risk mitigation, and audit readiness across all regulatory activities.

Scope

This SOP applies to all regulatory processes and activities including document preparation, submission management, compliance verification, and record retention within Regulatory Affairs. It covers electronic and paper-based workflows related to regulatory submissions, correspondence, and filing systems. The SOP is applicable across all products, dosage forms, and geographic regulatory jurisdictions handled by the organization. Activities outside regulatory operations such as manufacturing processes or laboratory testing are excluded.

Responsibilities

The responsibilities are assigned to functional roles as follows:

• Regulatory Affairs Specialists: Execute compliance checks, record observations, and implement corrective actions.
• Regulatory Affairs Supervisors: Review compliance assessments and oversee process adherence.
• Quality Assurance (QA): Verify compliance status, conduct independent reviews, and approve closure of deviations.
• Documentation Control: Ensure proper filing, version control, and archival of regulatory records.

Accountability

The Head of Regulatory Affairs is accountable for the implementation, compliance monitoring, periodic review, escalation of non-compliances, and ensuring the effectiveness of this SOP within the regulatory function. Accountability also includes ensuring appropriate training and resource allocation for compliance checks.

Procedure

The procedure for regulatory process compliance checks shall be executed as follows:

1. Preparation and Prerequisites: Prior to conducting the compliance check, ensure access to applicable regulations, internal procedures, guidelines, and up-to-date regulatory documentation. Verify that all necessary checklists and tools are available.

2. Review of Regulatory Documents and Records: Collect regulatory submissions, correspondence, and related records scheduled for review. Confirm that documentation is complete, properly authorized, and stored according to documentation control procedures.

3. Compliance Verification: Systematically assess adherence to relevant regulatory requirements, internal SOPs, and quality management system standards. Check for completeness, accuracy, proper versioning, and traceability of information.

4. In-Process Control Checks: Validate that all procedural steps were performed within required timelines and approved by authorized personnel. Review communication logs, approvals, and tracking systems for consistency.

5. Identification and Documentation of Deviations: Record any non-compliances or discrepancies identified during the check. Classify deviations based on their impact and notify the regulatory supervisor and QA for further action.

6. Review and Approval of Findings: Summarize findings in a compliance check report. Submit to Regulatory Affairs Supervisor and QA for review and approval. Ensure decisions on corrective or preventive actions are documented.

7. Corrective and Preventive Actions (CAPA): Implement CAPAs for identified deviations within agreed timelines. Monitor closure and effectiveness of actions taken.

8. Documentation and Record Retention: Maintain documented evidence of compliance checks, reports, CAPA, and approvals as per organizational document retention policy. Ensure records are readily retrievable for audits and inspections.

9. Training and Continuous Improvement: Provide feedback and training to regulatory staff based on compliance check outcomes. Periodically review and update the SOP to incorporate improvements aligned with evolving regulations.

This procedure ensures thorough and consistent compliance verification aligned with GMP and regulatory standards, fostering audit readiness and continual improvement within regulatory operations.

Abbreviations

• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RA: Regulatory Affairs

Documents

1. Regulatory Process Compliance Checklist (Annexure-1)
2. Compliance Check Report Template (Annexure-2)
3. Deviation and CAPA Form for Regulatory Non-Compliance (Annexure-3)

References

• EU GMP Guidelines, Annex 11 – Computerized Systems
• FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
• ICH Q10 – Pharmaceutical Quality System
• Company Quality Management System Manual
• Internal Document Control and Record Retention Policies

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Regulatory Process Compliance Checklist

Purpose: To provide a comprehensive list of checkpoints for assessing regulatory process compliance during audits and routine reviews.

Checklist Item	Yes / No / N/A	Comments
All regulatory documents are version controlled and approved.
Submission timelines are adhered to and documented.
Correspondence is logged and responded as per SOP.
Deviations are documented and CAPA implemented.
Records are stored securely with restricted access.
Regulatory guidelines and SOPs are available and referenced.
Regular training on compliance requirements has been completed.

Reviewer: ___________________      Date: 00/00/0000

Annexure-2: Compliance Check Report Template

Purpose: To document findings, observations, and conclusions of regulatory process compliance checks.

Report No.:	CR-2026-001
Date:	08/04/2026
Checked By:
Department:	Regulatory Affairs
Scope of Compliance Check: Regulatory submissions, documentation accuracy, timeline adherence
Summary of Findings: All documents reviewed were in compliance except for noted deviations. Minor delays in submission timelines observed in 2 cases. CAPA issued for identified deficiencies.
Recommendations: Implement enhanced tracking for submission deadlines. Conduct refresher training on documentation control.
Approval:

Annexure-3: Deviation and CAPA Form for Regulatory Non-Compliance

Purpose: To document deviations identified during compliance checks and track corrective and preventive actions.

Deviation No.:	DEV-2026-015
Date Identified:	08/04/2026
Area/Process:	Regulatory Submission Management
Description of Deviation:	Submission was delayed by 3 days beyond the regulatory deadline.
Immediate Action Taken:	Notified regulatory authority and submitted justification letter.
Root Cause Analysis:	Inadequate tracking of submission deadlines.
Corrective Actions:	Implemented enhanced submission tracking spreadsheet and alerts.
Preventive Actions:	Scheduled quarterly training on submission timeline management.
Responsible Person:
Target Completion Date:	30/05/2026
Verification of Effectiveness:	Follow-up audit scheduled for 30/06/2026.
Closure:	_______________________    Date: ____________

Revision History

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