Qualification Execution Checklist

Equipment: Coding Machine

Subcategory: Sterile Powders & Lyophilized Products

Area: Packaging

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

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs reviewed and acknowledged
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive maintenance completed

Protocol Readiness and Approvals

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

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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