Qualification Execution Checklist for Blister Packing Machine (Thermoform)

Equipment Information

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

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

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Qualification Protocol prepared
Protocol reviewed and approved by Engineering
Protocol reviewed and approved by Validation
Protocol reviewed and approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed