Qualification Execution Checklist for Crimping Machine (Pump Fixing)

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 operators
• Standard Operating Procedures (SOPs) reviewed and approved
• User Requirement Specification (URS) approved
• Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

• Calibration status verified
• Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

• Protocol documentation completed
• Protocol approved by relevant stakeholders

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording procedures adhered to
• Deviations documented and addressed

Review and Approvals

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