Qualification Execution Checklist for RABS / Isolator

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol finalized
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented and addressed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed