Qualification Execution Checklist for Case Packer

Equipment: Case Packer

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Packaging/Secondary

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) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Qualification Protocols prepared
Protocols approved by relevant stakeholders

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) review completed

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