Standard Operating Procedure for Periodic Compliance Check of Regulatory Document Systems

Department	Regulatory Affairs
SOP No.	RA/2026/783
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 procedure for conducting periodic compliance checks on regulatory document systems to ensure adherence to applicable regulatory requirements, internal quality standards, and data integrity principles. The goal is to maintain accuracy, completeness, traceability, and accessibility of regulatory documents throughout their lifecycle, thereby supporting regulatory submissions, inspections, and audits effectively.

Scope

This SOP covers all regulatory document management systems used within the organization, including electronic and hardcopy records related to regulatory submissions, correspondence, certifications, approvals, and archival. It applies to all departments involved in creation, review, approval, maintenance, and archival of regulatory documents. Excluded are operational documents unrelated to regulatory compliance such as standard manufacturing batch records or laboratory test data not submitted to regulatory agencies.

Responsibilities

• Regulatory Affairs Team: Execute periodic compliance checks, identify discrepancies, and initiate corrective actions.
• Quality Assurance: Review compliance check findings and provide oversight.
• Document Control: Support in document retrieval, record updates, and archiving activities.
• Department Heads: Ensure corrective actions are implemented in their respective areas.
• Compliance Officer: Monitor overall adherence and escalate major risks.

Accountability

The Head of Regulatory Affairs is accountable for the implementation, compliance, periodic review, and effectiveness of this SOP. This role ensures escalation of non-compliance issues and drives continuous improvement in regulatory document management systems.

Procedure

1. Preparation:
a) Identify the schedule for periodic compliance checks as per the annual quality plan.
b) Gather the list of regulatory document systems, both electronic and physical, including submission files, correspondence logs, approval records, and archival registries.
c) Review applicable regulatory requirements, internal SOPs, and previous audit or inspection findings to focus the compliance check scope.

2. Prerequisites:
a) Ensure access rights to document management systems.
b) Obtain necessary tools such as checklists, templates, and audit records for documentation.
c) Confirm availability of responsible personnel for interviews if required.
d) Follow all safety, security, and GMP protocols relevant to document handling.

3. Execution:
a) Verify that documents are properly categorized, numbered, and version-controlled according to SOPs.
b) Confirm the completeness of document sets, ensuring no pages or data are missing.
c) Check that document approval signatures, dates, and stamps comply with authorized workflows.
d) Assess the integrity of archival storage conditions to prevent deterioration or loss.
e) Review electronic database logs for unauthorized access, modifications, or deletion.
f) Validate that retention periods are adhered to and obsolete documents are disposed of according to policy.
g) Record any deviations, discrepancies, or non-compliance immediately in compliance check report forms.
h) Coordinate with the Quality Assurance team for complex findings or potential regulatory risks.

4. Verification and Acceptance Criteria:
a) Ensure 100% of sampled documents meet all regulatory, procedural, and quality standards.
b) Confirm that corrective actions from prior checks have been implemented and are effective.
c) Validate that the document management system supports traceability from creation to archival.
d) Accept final compliance report only after addressing all critical and major observations.

5. Deviations and Approvals:
a) Document all deviations from compliance parameters clearly.
b) Evaluate significance and initiate CAPA (Corrective and Preventive Actions) as applicable.
c) Obtain review and approval signatures from the responsible regulatory, QA, and compliance representatives.
d) Schedule follow-up reviews for unresolved issues.

6. Documentation and Record Retention:
a) Complete compliance check reports with all findings, evidence, and corrective action plans.
b) Retain reports and related records in the regulatory document system under designated folders.
c) Ensure documentation is available for internal audits and external inspections.
d) Update any SOPs or training materials if procedural improvements are identified.

7. Closure:
a) Communicate the compliance check outcomes to senior management.
b) Verify closure of CAPA items during subsequent compliance checks.
c) Continuously monitor the effectiveness of document management systems and update SOPs accordingly.

Abbreviations

• CAPA – Corrective and Preventive Action
• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• RA – Regulatory Affairs
• SOP – Standard Operating Procedure
• CFR – Code of Federal Regulations

Documents

The following documents are necessary for the execution and documentation of the periodic compliance check on regulatory document systems:

1. Periodic Compliance Check Report (Annexure-1)
2. Corrective Action Plan Template (Annexure-2)
3. Regulatory Document Inventory List (Annexure-3)

References

• FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Annex 11 EU GMP – Computerised Systems
• ICH Q10 – Pharmaceutical Quality System
• Internal Document Control SOP
• Data Integrity Guidance by WHO and MHRA

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Periodic Compliance Check Report

Title	Periodic Compliance Check Report
Purpose	To document the findings and outcomes of the periodic compliance check of regulatory document systems.

Report Details

Report ID	CCR-2026-0417
Date of Check	15/04/2026
Checked By	[Name / Signature]
Documents Reviewed	Regulatory submissions, correspondence files, archival registries
Findings Summary	All documents verified as compliant except minor missing approval dates in two files.
Deviations	Two cases of missing approval date stamps documented.
Corrective Actions	Implement additional training for document control team; reinforce approval signature requirement.
Reviewer Comments	Timely review appreciated, prompt closure of CAPAs required.
Reviewer Signature	__________________
Date	17/04/2026

Annexure-2: Corrective Action Plan Template

Title	Corrective Action Plan
Purpose	To outline planned corrective and preventive actions arising from the compliance check.

CAPA Details

CAPA ID	CAPA-2026-0417-01
Date Initiated	17/04/2026
Description of Issue	Missing approval dates in regulatory document files.
Root Cause Analysis	Inadequate training on document approval workflow.
Corrective Action	Conduct refresher training session on document control requirements.
Preventive Action	Update SOP to highlight critical approval elements and include checklist verification.
Implementation Responsible	Document Control Supervisor
Target Completion Date	30/04/2026
Verification Outcome	To be completed during next compliance check.
Verified By
Date Verified

Annexure-3: Regulatory Document Inventory List

Title	Regulatory Document Inventory
Purpose	To maintain a current inventory of all regulatory documents managed by the department.

Inventory Sample

Document ID	Title / Description	Version	Location	Retention Period	Status
RD-001	Marketing Authorization Application – Product A	3.2	Electronic Repository / Folder RA_Submissions	10 years post expiry	Active
RD-002	Regulatory Correspondence Log 2025-2026	1.0	Physical Archive Room 2 / Shelf B	5 years	Archived
RD-003	Certification of Compliance from Health Authority	1.1	Electronic Repository / Certificates	Permanent	Active

Revision History

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