Qualification Execution Checklist for Extrusion Machine

Equipment: Extrusion Machine

Subcategory: Implants (Drug-Eluting / Biodegradable)

Area: Production

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance completed

Protocol Readiness and Approvals

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

Execution Controls

GDP adhered to
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed