Qualification Execution Checklist for Blow-Fill-Seal (BFS) Machine

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

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) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol prepared and finalized
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed accurately
Deviations documented and managed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed