Qualification Execution Checklist

Equipment: Spray Dryer (Respirable Particles)

Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles)

Area: R&D/Production

DQ/IQ/OQ/PQ Flags: 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 schedule followed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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