Qualification Execution Checklist

Equipment: Vial Washing Machine

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) approved

Calibration/PM Status Verification

Calibration records verified
Preventive Maintenance (PM) status confirmed

Protocol Readiness and Approvals

Qualification Protocol prepared
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed