Tag: EXECUTION-CHECKLIST

Leak Test Machine (CCIT) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Leak Test Machine (CCIT) Subcategory: Prefilled Syringes & Cartridges Area: Production/QC DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM…

Lyophilizer (Freeze Dryer) – NDDS – Qualification Execution Checklist

Qualification Execution Checklist for Lyophilizer (Freeze Dryer) – NDDS Production Area 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) completed Protocol Readiness…

Cap Tightening Machine – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Cap Tightening Machine Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production/Packaging 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) approved Calibration/PM…

Vent Filter (Sterile Gas Filter Assembly) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Vent Filter (Sterile Gas Filter Assembly) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Approval (RA) obtained Calibration/PM Status Verification…

Serialization System – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Serialization System Subcategory: Suppositories & Implants Area: Packaging DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM schedule adhered to Protocol Readiness and…

Lyophilizer Stoppering System – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Lyophilizer Stoppering System Subcategory: Sterile Powders & Lyophilized Products Area: Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status verified Protocol Readiness…

Lyophilizer (if lyophilized syringe/cartridge) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Lyophilizer Subcategory: Prefilled Syringes & Cartridges Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM completed Protocol Readiness and Approvals Protocol…

VHP Decontamination Unit (if isolator/RABS) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: VHP Decontamination Unit Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production 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…

VHP Generator / Decontamination Unit – Qualification Execution Checklist

Qualification Execution Checklist Equipment: VHP Generator / Decontamination Unit Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration…