Sterile Holding Tank Qualification Execution Checklist

Equipment: Sterile Holding Tank (Pressurized)

Subcategory: Sterile Powders & Lyophilized Products

Area: Production

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs reviewed and 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

Qualification Protocol drafted
Qualification Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures adhered to
Deviations documented and addressed

Review and Approvals

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

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