Lyophilizer (Freeze Dryer) – Qualification Execution Checklist

Qualification Execution Checklist for Lyophilizer (Freeze Dryer)

Subcategory: Sterile Powders & Lyophilized Products

Area: Production

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

CSV Required: Yes

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

Qualification Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented and managed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed