Qualification Execution Checklist for Tablet Press (Bilayer/Multilayer)

Equipment: Tablet Press (Bilayer/Multilayer)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Compression

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration completed
PM status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

GDP followed
Data recorded
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed