Qualification Execution Checklist

Equipment: Checkweigher (Inline)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Packaging/Primary

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
URS approved
Regulatory Affairs (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol finalized
Approvals obtained from all stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented and addressed

Review and Approvals

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

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