Qualification Execution Checklist

Equipment: Sterility Test Isolator / System (if NDDS sterile)

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: Microbiology

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

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs approved
URS approved
Regulatory Affairs approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

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

Review and Approvals

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

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