Qualification Execution Checklist

Equipment: Jet Mill / Micronizer

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

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

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol finalized
Approvals obtained from all stakeholders

Execution Controls

GDP followed
Data recording completed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed