Qualification Execution Checklist for Pump Assembly Machine (Nasal)

Equipment Details

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production

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

CSV Required: Yes

Pre-start Checks

• Training completed for all operators
• Standard Operating Procedures (SOPs) reviewed and approved
• User Requirements Specification (URS) approved
• Regulatory Approval (RA) obtained

Calibration/PM Status Verification

• Calibration status verified and up to date
• Preventive Maintenance (PM) records reviewed

Protocol Readiness and Approvals

• Qualification Protocols (DQ/IQ/OQ/PQ) prepared
• Protocols reviewed and approved by relevant stakeholders

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording methods verified
• Procedures for handling deviations established

Review and Approvals

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