Qualification Execution Checklist for Fluid Bed Processor (FBP) – Granulation

Equipment Information

Equipment: Fluid Bed Processor (FBP) – Granulation

Subcategory: Solid Dosage Form (OSD)

Area: Production/Granulation

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

CSV Required: Yes

Pre-start Checks

• Training completed for all personnel involved
• Standard Operating Procedures (SOPs) approved
• User Requirements Specification (URS) approved
• Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

• Calibration status verified
• Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

• Qualification Protocol prepared
• Protocol approvals obtained from all necessary stakeholders

Execution Controls

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

Review and Approvals

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