Capsule Checkweigher – Qualification Execution Checklist

Qualification Execution Checklist for Capsule Checkweigher

Equipment Details

Subcategory: Solid Dosage Form (OSD)

Area: Production/Capsules

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

CSV Required: Yes

Pre-Start

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed and approved

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) review completed

See also Plunger Insertion Machine – DQ Protocol