Regulatory Submission Readiness Checklist [FREE PDF]

This regulatory submission readiness checklist ensures compliance with ICH M4 CTD Common Technical Document requirements. Regulatory Affairs Managers use this checklist to verify regulatory compliance, document findings, and maintain safety and quality standards.

Industry: Pharmaceutical
Frequency: Per Submission
Estimated Time: 8-40 hours
Role: Regulatory Affairs Manager
Total Items: 21
Compliance: ICH M4 CTD Common Technical Document, FDA 21 CFR 314 NDA Submissions, EU GMP Annex 16 QP Release, ICH Q8/Q9/Q10 Quality Guidelines

Documentation and Regulatory Review

Verify required documentation is current and complete.

Standard Operating Procedures (SOPs) current and accessible?
All personnel training records current for this activity?
Required permits, licenses, and registrations current?
Previous inspection findings reviewed and corrective actions verified?

Safety and Equipment Requirements

Verify safety equipment, PPE, and emergency preparations.

Required PPE available, clean, and in good condition?
Emergency equipment (eyewash, shower, extinguisher) accessible?
Safety Data Sheets (SDS) available for all hazardous materials?
Emergency contact and response procedures posted?

Operational Compliance Checks

Verify operations comply with regulatory requirements.

Approved procedures being followed without deviation?
Equipment qualified/calibrated and within calibration period?
Environmental monitoring (temp, humidity, pressure) within spec?
All materials, products, and containers properly labeled?
Data recorded contemporaneously with no unexplained alterations?

Waste Disposal and Environmental Compliance

Verify proper waste handling and disposal.

All waste properly labeled with contents and hazard class?
Waste containers appropriate for waste type and in good condition?
Waste streams segregated per regulatory requirements?
Waste disposal records maintained?

Findings and CAPA

Document findings and corrective/preventive actions.

Any deviations or non-conformances identified?
CAPA initiated for any findings?
Photo documentation of findings?
Inspection findings and recommendations

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Why Use This Regulatory Submission Readiness Checklist [FREE PDF]?

This regulatory submission readiness checklist [free pdf] helps pharmaceutical teams maintain compliance and operational excellence. Designed for regulatory affairs manager professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: per submission.

Ensures compliance with ICH M4 CTD Common Technical Document, FDA 21 CFR 314 NDA Submissions, EU GMP Annex 16 QP Release, ICH Q8/Q9/Q10 Quality Guidelines. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Regulatory Submission Readiness Checklist [FREE PDF] cover?

This checklist covers 21 inspection items across 5 sections: Documentation and Regulatory Review, Safety and Equipment Requirements, Operational Compliance Checks, Waste Disposal and Environmental Compliance, Findings and CAPA. It is designed for pharmaceutical operations and compliance.

How often should this checklist be completed?

This checklist should be completed per submission. Each completion takes approximately 8-40 hours.

Who should use this Regulatory Submission Readiness Checklist [FREE PDF]?

This checklist is designed for Regulatory Affairs Manager professionals in the pharmaceutical industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.