CCIT System (Vacuum Decay/Helium/HVLD) – Qualification Execution Checklist

Qualification Execution Checklist for CCIT System

Equipment: CCIT System (Vacuum Decay/Helium/HVLD)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: QC/Production

Pre-start

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted and reviewed
Protocol approved by relevant stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed
Deviations documented and addressed

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

CSV Required

CSV documentation prepared
CSV approval obtained