Qualification Execution Checklist: Sterile Holding Tank

Equipment Information

• Subcategory: Prefilled Syringes & Cartridges
• Area: Production
• DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
• CSV Required: Yes

Pre-Start Checks

• Training completed for all personnel
• Standard Operating Procedures (SOPs) approved
• User Requirement Specification (URS) approved
• Regulatory Approval (RA) obtained

Calibration/PM Status Verification

• Calibration status verified and documented
• Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

• Protocol drafted and reviewed
• Protocol approvals obtained from relevant stakeholders

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording procedures in place
• Deviations documented and addressed

Review and Approvals

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