Qualification Execution Checklist

Equipment: Sigma Mixer / Kneader

Subcategory: Solid Dosage Form (OSD)

Area: Production/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 status verified

Protocol Readiness and Approvals

Protocol finalized
Approvals obtained

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations logged

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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