Qualification Execution Checklist

Equipment: Implant Mixing Vessel (Jacketed SS)

Subcategory: Implants (Drug-Eluting / Biodegradable)

Area: Production

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol completed
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

GDP compliance verified
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed