Qualification Execution Checklist for Capper (Screw Cap)

Equipment Details

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

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

CSV Required: Yes

Pre-start Verification

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

Calibration/PM Status Verification

• Calibration status verified
• Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

• Qualification Protocols drafted
• Protocols reviewed and approved

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording procedures in place
• Deviations documented and addressed

Review and Approvals

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