Qualification Execution Checklist

Equipment: Syringe Stoppering Machine

Subcategory: Prefilled Syringes & Cartridges

Area: Production

DQ/IQ/OQ/PQ: 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
PM status verified

Protocol Readiness and Approvals

Protocol completed
Approvals obtained

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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