Qualification Execution Checklist

Equipment: Plunger Insertion Machine

Subcategory: Prefilled Syringes & Cartridges

Area: Production

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol ready for execution
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