DPI – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: DPI

Subcategory: Inhalers (MDI)

Area: MDI Bulk Compounding Vessel (Jacketed SS)

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol ready for execution
Protocol approved by all stakeholders

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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