Prefilled Syringe Filling Machine – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Prefilled Syringe Filling 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
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed
Deviations documented and addressed

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

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