Qualification Execution Checklist

Equipment: Solvent Addition / Metering Pump

Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.)

Area: R&D/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
Preventive Maintenance completed

Protocol Readiness and Approvals

Protocol finalized
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