Qualification Execution Checklist

Equipment: Lyophilizer SCADA / Control System

Subcategory: Sterile Powders & Lyophilized Products

Area: System

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

CSV Required: Yes

Pre-start

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

Calibration/PM Status Verification

Calibration records verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Qualification Protocols prepared
Protocols reviewed and approved by Engineering
Protocols reviewed and approved by Validation
Protocols reviewed and approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviation management process established

Review and Approvals

Engineering review completed
Validation review completed
QA review completed