Qualification Execution Checklist

Equipment: Syringe Assembly Machine (Needle Attachment)

Subcategory: Prefilled Syringes & Cartridges

Area: Production

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

CSV Required: Yes

Pre-Start Checks

Training Completed
SOPs Reviewed
URS Approved
RA Approved

Calibration/PM Status Verification

Calibration Status Verified
PM Status Verified

Protocol Readiness and Approvals

Protocol Draft Completed
Protocol Reviewed
Protocol Approved

Execution Controls

GDP Compliance Confirmed
Data Recording Procedures Followed
Deviations Documented

Review and Approvals

Engineering Review Completed
Validation Review Completed
QA Review Completed

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