Qualification Execution Checklist for Ophthalmic Filling Machine (Dropper Bottles)
Equipment Details
Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)
Area: Production
DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes
CSV Required: Yes
Pre-start Checks
- Training completed
- SOPs reviewed and approved
- URS approved
- Regulatory Affairs approved
Calibration/PM Status Verification
- Calibration status verified
- Preventive Maintenance (PM) status verified
Protocol Readiness and Approvals
- Protocol drafted
- Protocol approved by Engineering
- Protocol approved by Validation
- Protocol approved by QA
Execution Controls
- Good Documentation Practices (GDP) followed
- Data recording completed
- Deviations documented
Review and Approvals
- Engineering review completed
- Validation review completed
- QA review completed