Qualification Execution Checklist

Equipment: Leak Test Machine (Container Closure)

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production/QC

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol finalized
Protocol approvals obtained

Execution Controls

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

Review and Approvals

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

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