Shaking Incubator – Qualification Execution Checklist

Qualification Execution Checklist: Shaking Incubator

Area: Production/Cell Culture

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

CSV Required: Yes

Pre-Start

Training completed
SOPs reviewed and 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 Protocols prepared
Protocols reviewed and approved

Execution Controls

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

Review and Approvals

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

See also Spray Dryer (Respirable Particles) – Traceability Matrix (URS ↔ Tests)