Qualification Execution Checklist

Equipment: Flake Crusher (Post-Roller Compaction)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Dry Granulation

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

Pre-start

Training completed
SOPs 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 recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained