Suppository Base Melting Vessel (Jacketed SS) – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Suppository Base Melting Vessel (Jacketed SS)

Subcategory: Suppositories & Implants

Area: Production

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

CSV Required: Yes

Pre-Start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM schedule adhered to

Protocol Readiness and Approvals

Protocol drafted
Protocol 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
QA review completed

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