Qualification Execution Checklist for Lyophilizer (Freeze Dryer) – NDDS

Production Area

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) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented

Review and Approvals

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

CSV Required

Computer System Validation (CSV) documentation available