Qualification Execution Checklist

Equipment: Homogenizer (Inline / High Shear)

Subcategory: Suppositories & Implants

Area: Production

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

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs reviewed and approved
User Requirement Specification (URS) approved
Regulatory Approval (RA) obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

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