Qualification Execution Checklist

Equipment: Labeling Machine

Subcategory: Suppositories & Implants

Area: Packaging

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval received

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Qualification Protocol drafted
Qualification Protocol approved
Change Control documentation completed

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures followed
Deviations documented and reported

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) approval received

Submit Checklist