Regulatory Affairs Audit Checklist

1. Regulatory Submissions & Approvals

• Dossier submissions (CTD/eCTD/ACTD) prepared and archived properly.

• Records of Marketing Authorization Applications (MAA), IND, NDA, ANDA, DMF, CEP maintained.

• Approval letters from health authorities (FDA, EMA, CDSCO, MHRA, etc.) available.

• Renewal of licenses/approvals tracked and updated.

• Variations/changes (major/minor) submitted and approvals documented.

2. Product Registration & Lifecycle Management

• Master list of all registered products with status (approved, pending, under review).

• Country-wise registration status and validity maintained.

• Post-approval commitments tracked (e.g., stability data submissions, PSUR/PBRER).

• Changes in formulation, packaging, manufacturing site documented and notified to regulatory bodies.

3. Regulatory Correspondence

• Communication with regulatory authorities properly archived.

• Queries from authorities responded to within stipulated timelines.

• Records of deficiency letters and company’s responses maintained.

• Tracking system for commitments and deadlines in place.

4. Labeling & Artwork Compliance

• Product labeling and package inserts comply with local regulations.

• Change control system in place for labeling updates.

• Translations (if required) accurate and verified.

• Artwork approval records documented and controlled.

5. Pharmacovigilance & Safety Reporting

• System for reporting of adverse events (AE/SAE) established.

• PSURs/PBRERs submitted on time to authorities.

• Risk Management Plans (RMPs) available where required.

• Safety variations communicated to regulatory authorities.

6. Regulatory Intelligence & Compliance

• Monitoring system for updated guidelines, ICH, WHO, USFDA, EMA, CDSCO regulations.

• Gap assessments performed for new regulatory requirements.

• Internal SOPs aligned with current global regulatory standards.

• Training provided to staff on new regulatory updates.

7. Documentation & Record Control

• Regulatory documents controlled under QMS (with version control).

• Archival system for dossiers, approvals, and correspondence.

• Electronic document management system (if used) validated.

• Confidential documents secured and access controlled.

8. Cross-functional Coordination

• RA alignment with QA/QC, R&D, Production, and PV teams.

• RA input provided in product development and technology transfer.

• Change control notifications reviewed and assessed for regulatory impact.

9. Audits & Inspections

• Preparedness for health authority inspections (e.g., USFDA, EMA, CDSCO).

• Records of previous audits/inspections and CAPAs implemented.

• Self-inspection of RA activities carried out periodically.

✅ Tip: Ensure ALCOA+ principles are applied in all RA documentation for data integrity.

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