Glass Lined Reactor (GLR) – Qualification Execution Checklist

Qualification Execution Checklist for Glass Lined Reactor (GLR)

Area: Production

Subcategory: API Manufacturing (Chemical Synthesis & Purification)

Pre-start

Training completed
SOPs approved
User Requirements Specification (URS) approved
Regulatory Approval (RA) obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed