Binder Solution Preparation Tank – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Binder Solution Preparation Tank

Subcategory: Solid Dosage Form (OSD)

Area: Production/Granulation

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

Pre-start

Training completed
SOPs reviewed and approved
User Requirement Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

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

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed