Qualification Execution Checklist for Implant Coating Machine

Equipment: Implant Coating Machine

Subcategory: Implants (Drug-Eluting / Biodegradable)

Area: Production

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

CSV Required: Yes

Pre-Start Checks

Training completed for all operators
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration records reviewed
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 addressed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed